| 2026-03-19 |
Class I
|
Ongoing |
Z-1981-2026 |
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo… |
— |
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full di… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0187-2026 |
Medical convenience kits IHDC30R D AND C PACK |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0186-2026 |
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0185-2026 |
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0184-2026 |
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0183-2026 |
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCN… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0182-2026 |
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0181-2026 |
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BA… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0180-2026 |
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0179-2026 |
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0178-2026 |
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951 |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0177-2026 |
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CEN… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0176-2026 |
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PAC… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0175-2026 |
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0174-2026 |
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0173-2026 |
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0172-2026 |
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASI… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0171-2026 |
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC… |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-09-04 |
Class II
|
Ongoing |
Z-0170-2026 |
Basic Biopsy Tray, Item Number NMBP44L |
— |
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2472-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2471-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2470-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2469-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLB… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2468-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NU… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2467-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item … |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2466-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYS… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2465-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L;… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2464-2025 |
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANC… |
— |
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are… |
| 2025-04-21 |
Class II
|
Ongoing |
Z-1916-2025 |
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, … |
— |
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, whic… |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1362-2025 |
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1361-2025 |
THORACIC PACK , Model No UTTC82Y UTTC82AA-01 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1360-2025 |
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1359-2025 |
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1358-2025 |
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1357-2025 |
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1356-2025 |
AV FISTULA , Model No UTAV77T |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1355-2025 |
NEURO IR TRAY , Model No WENI56J |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1354-2025 |
DIAGNOSTIC NEURO IR TRAY , Model No WENE21 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1353-2025 |
CV BASIC PUMP PACK , Model No WECV23D |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1352-2025 |
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1351-2025 |
EAR PACK , Model No SFEA12A |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1350-2025 |
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1349-2025 |
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1348-2025 |
DELIVERY PACK , Model No SGDV22D-01 SGDV22E |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1347-2025 |
TOTAL HIP PACK , Model No SMTH06O SMTH06P |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1346-2025 |
CYSTO , Model No SACY80R |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1345-2025 |
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1344-2025 |
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1343-2025 |
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1342-2025 |
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1341-2025 |
BORN ON ARRIVAL KIT , Model No LLBN11B |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1340-2025 |
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1339-2025 |
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1338-2025 |
LABOR & DELIVERY PACK, Model Nos LLLD19H |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1337-2025 |
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1336-2025 |
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1335-2025 |
CYSTO PACK , Model N. HKCY31A |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1334-2025 |
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1333-2025 |
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1332-2025 |
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1331-2025 |
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G |
— |
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2025-02-04 |
Class II
|
Ongoing |
Z-1406-2025 |
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. |
— |
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suita… |
| 2025-01-31 |
Class II
|
Ongoing |
Z-1426-2025 |
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Sof… |
— |
Sterility assurance with procedure trays |
| 2025-01-31 |
Class II
|
Ongoing |
Z-1425-2025 |
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A… |
— |
Sterility assurance with procedure trays |
| 2025-01-31 |
Class II
|
Ongoing |
Z-1424-2025 |
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Conveni… |
— |
Sterility assurance with procedure trays |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3244-2024 |
Pacemaker, COPM11B; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3243-2024 |
Cysto, FTCY03L; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3242-2024 |
Nasal Sinus Pack, MTSN26B; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3241-2024 |
ENT, COEN27N; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3240-2024 |
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3239-2024 |
Cath Lab Pack, CECL02P; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3238-2024 |
Vaginal Delivery, ASDV25B; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3237-2024 |
Hand Pack, AKHD97C; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3236-2024 |
Neuro Vascular, ANKV91A; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3235-2024 |
IR Procedure Pack, CEAT19W; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3234-2024 |
Paracentesis Thoracente, SLPT76H; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3233-2024 |
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3232-2024 |
Shoulder, SESH18I; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3231-2024 |
Day Surgery General Pack, FHGE18T; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3230-2024 |
Open Shoulder, LWOS39L; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3229-2024 |
Arthroscopy Pack, MSKA45A; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3228-2024 |
Endovascular AAA Pack, ESED52B; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3227-2024 |
Endovascular AAA Pack, ESED52B; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3226-2024 |
PACEMAKER PACK, SLCV01J; Medical convenience kit |
— |
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, AC… |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2312-2024 |
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2311-2024 |
HAND PACK-Procedure Kit Catalog Number: WEHD16C |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2310-2024 |
HAND PACK-Procedure Kit Catalog Number: WEHD16B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2309-2024 |
ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2308-2024 |
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2307-2024 |
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2306-2024 |
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2305-2024 |
TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2304-2024 |
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2303-2024 |
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2302-2024 |
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2301-2024 |
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2300-2024 |
HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2299-2024 |
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2298-2024 |
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2297-2024 |
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2296-2024 |
TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2295-2024 |
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2294-2024 |
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2293-2024 |
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2292-2024 |
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2291-2024 |
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2290-2024 |
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2289-2024 |
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2288-2024 |
UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2287-2024 |
KNEE SCOPE Procedure tray Catalog Number: COKN48L |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2286-2024 |
HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2285-2024 |
FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2284-2024 |
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2283-2024 |
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2282-2024 |
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2281-2024 |
ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2280-2024 |
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2279-2024 |
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2278-2024 |
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2277-2024 |
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2276-2024 |
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2275-2024 |
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-15 |
Class II
|
Ongoing |
Z-2274-2024 |
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K |
— |
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated … |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2524-2024 |
American Contract Systems Spine Pack convenience kit |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2523-2024 |
American Contract Systems Biopsy Drape Pack convenience kit |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise… |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2522-2024 |
American Contract Systems Cataract Pack convenience kit |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2521-2024 |
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American C… |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise… |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2520-2024 |
American Contract Systems Special Procedure Pack convenience kit |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise… |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2519-2024 |
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience… |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise… |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2518-2024 |
American Contract Systems Gyn Laparoscopy convenience kit |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise… |
| 2024-05-06 |
Class II
|
Ongoing |
Z-2517-2024 |
American Contract Systems Hand Pack convenience kit |
— |
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromise… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0833-2024 |
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HI… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0832-2024 |
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Lamine… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0831-2024 |
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0830-2024 |
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit num… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0829-2024 |
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, … |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0828-2024 |
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit … |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0827-2024 |
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J;… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0826-2024 |
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J;… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0825-2024 |
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0824-2024 |
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit num… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0823-2024 |
Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; … |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0822-2024 |
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0821-2024 |
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit n… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0820-2024 |
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGT… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0819-2024 |
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52;… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0818-2024 |
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0817-2024 |
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G;… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0816-2024 |
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA0… |
— |
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0182-2024 |
Cath Cardiac Pack, REF IHCC03V |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0181-2024 |
Pediatric Urology Wolson Pack, REF BPPU55A |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0180-2024 |
Sub Q Recorder Pack, REF BPRC87A |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0179-2024 |
Robotics Pack, REF SSRO22D |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0178-2024 |
Robotics Pack, REF SJVO56B |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0177-2024 |
Vasc. Open CVOR SJH, REF SJVO56B |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0176-2024 |
Pediatric Heart SJH, REF SJPH34K |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0175-2024 |
CVS PCSU SJH, REF SJCV48J |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0174-2024 |
Robotics Pack SAH, REF SAR530M |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0173-2024 |
Breast Plastics Pack, REF BBPL20D |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0172-2024 |
LAVH, REF BBLV21C |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-09-01 |
Class II
|
Ongoing |
Z-0171-2024 |
General Pack, REF BBGP31C |
— |
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inad… |
| 2023-04-17 |
Class III
|
Ongoing |
Z-1973-2023 |
Total Knee Pack, REF CETJ130, medical convenience kits |
— |
Incorrect expiration date on product. |
| 2022-10-12 |
Class II
|
Terminated |
Z-0274-2023 |
BASIN SET, MEBS42K, general surgical kit |
— |
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on th… |
| 2022-08-12 |
Class II
|
Ongoing |
Z-0071-2023 |
COVID Test Kit Nonsterile |
— |
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1705-2022 |
Various eye packs, cataract packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1704-2022 |
D&C pack |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1703-2022 |
Various C-section packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1702-2022 |
Various hysterectomy, vaginal packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1701-2022 |
Various ob/gyn packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1700-2022 |
Various neurology packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1699-2022 |
Various convenience packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1698-2022 |
Various convenience packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1697-2022 |
Breast Abdominoplasty Pack |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1696-2022 |
Various Port Insertion Packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1695-2022 |
Various Cysto Packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1694-2022 |
Various Laparoscopy Packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1693-2022 |
Various ENT Packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1692-2022 |
Various PICC Line, Central Line Packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1691-2022 |
Various Pacemaker Packs, Cardio Thoracic Packs |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1690-2022 |
Various Angiography/Cath Lab packs/trays |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1689-2022 |
Various Angiography packs/trays |
— |
Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2022-05-02 |
Class I
|
Ongoing |
Z-1277-2022 |
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A |
— |
Affected products were assembled off-site by individuals who may not have been properly trained. |
| 2022-05-02 |
Class I
|
Ongoing |
Z-1276-2022 |
Clean Catch Urine Kit NS 178489, AHMU58A |
— |
Affected products were assembled off-site by individuals who may not have been properly trained. |
| 2022-03-22 |
Class II
|
Ongoing |
Z-1040-2022 |
ACS Cath Lab Pack |
— |
Product was sterilized with a higher than specification EO concentration. |
| 2022-03-22 |
Class II
|
Ongoing |
Z-1039-2022 |
ACS Lap Chole Pack |
— |
Product was sterilized with a higher than specification EO concentration. |
| 2022-03-22 |
Class II
|
Ongoing |
Z-1038-2022 |
ACS IR - Angio Pack |
— |
Product was sterilized with a higher than specification EO concentration. |
| 2022-03-22 |
Class II
|
Ongoing |
Z-1037-2022 |
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack |
— |
Product was sterilized with a higher than specification EO concentration. |
| 2022-03-22 |
Class II
|
Ongoing |
Z-1036-2022 |
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray |
— |
Product was sterilized with a higher than specification EO concentration. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2179-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2178-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2177-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2176-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2175-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2174-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2173-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2172-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2171-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2170-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2169-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2168-2020 |
Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2167-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| 2020-04-13 |
Class II
|
Terminated |
Z-2166-2020 |
Sterile Custom Packs to be used in surgical procedures. |
— |
The surgical gowns were manufactured in a facility that is not registered by the FDA. |