| 2026-04-07 |
Class II
|
Ongoing |
Z-1983-2026 |
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use |
— |
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce … |
| 2026-04-07 |
Class II
|
Ongoing |
Z-1982-2026 |
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use |
— |
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce … |
| 2026-01-27 |
Class II
|
Ongoing |
Z-1496-2026 |
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. |
— |
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. |
| 2025-10-23 |
Class II
|
Ongoing |
Z-0484-2026 |
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; |
— |
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instr… |
| 2025-10-14 |
Class II
|
Ongoing |
Z-0504-2026 |
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; |
— |
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. |
| 2025-09-23 |
Class II
|
Ongoing |
Z-0240-2026 |
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro d… |
— |
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se… |
| 2025-09-23 |
Class II
|
Ongoing |
Z-0239-2026 |
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers… |
— |
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se… |
| 2025-09-23 |
Class II
|
Ongoing |
Z-0238-2026 |
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Cata… |
— |
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se… |
| 2025-09-23 |
Class II
|
Ongoing |
Z-0237-2026 |
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. … |
— |
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se… |
| 2025-09-23 |
Class II
|
Ongoing |
Z-0236-2026 |
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: … |
— |
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se… |
| 2025-09-23 |
Class II
|
Ongoing |
Z-0235-2026 |
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog… |
— |
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se… |
| 2025-06-23 |
Class II
|
Ongoing |
Z-2162-2025 |
BD COR System Software. Model Number: 444829. |
— |
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results. |
| 2025-05-20 |
Class II
|
Ongoing |
Z-2023-2025 |
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul… |
— |
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates. |
| 2025-02-12 |
Class II
|
Ongoing |
Z-1296-2025 |
BD BBL TB Stain Kit K, Catalog (REF): 212522 |
— |
One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025. |
| 2024-12-19 |
Class II
|
Ongoing |
Z-1004-2025 |
BD PCR Cartridges used with MAX System. Model Number: 437519 |
— |
Potential for signal drift in specific lots of BD PCR Cartridges. |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0621-2025 |
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitat… |
— |
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0596-2025 |
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0595-2025 |
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0594-2025 |
BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0593-2025 |
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0592-2025 |
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0591-2025 |
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0590-2025 |
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0589-2025 |
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0588-2025 |
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0587-2025 |
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0586-2025 |
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0585-2025 |
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0584-2025 |
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007 |
— |
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti… |
| 2024-09-12 |
Class II
|
Ongoing |
Z-0026-2025 |
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory sof… |
— |
Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectl… |
| 2024-08-01 |
Class II
|
Ongoing |
Z-3247-2024 |
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically s… |
— |
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis a… |
| 2024-08-01 |
Class II
|
Ongoing |
Z-3246-2024 |
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of … |
— |
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis a… |
| 2024-07-18 |
Class II
|
Ongoing |
Z-2686-2024 |
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from c… |
— |
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. |
| 2024-07-09 |
Class II
|
Ongoing |
Z-2585-2024 |
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900; |
— |
There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would imp… |
| 2024-05-07 |
Class II
|
Ongoing |
Z-2023-2024 |
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swa… |
— |
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. |
| 2024-02-29 |
Class II
|
Ongoing |
Z-1399-2024 |
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene … |
— |
Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a pa… |
| 2024-02-29 |
Class II
|
Ongoing |
Z-1398-2024 |
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene … |
— |
Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in re… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1040-2024 |
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 a… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1039-2024 |
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1038-2024 |
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and … |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1037-2024 |
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catal… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1036-2024 |
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1035-2024 |
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1034-2024 |
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1033-2024 |
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 an… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1032-2024 |
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 … |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1031-2024 |
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1030-2024 |
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 an… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1029-2024 |
BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1028-2024 |
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 2316… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1027-2024 |
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1026-2024 |
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1025-2024 |
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1024-2024 |
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 … |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1023-2024 |
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1022-2024 |
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1021-2024 |
BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1020-2024 |
BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1019-2024 |
BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1018-2024 |
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1017-2024 |
BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿ |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1016-2024 |
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 23164… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1015-2024 |
BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing. |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1014-2024 |
BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing. |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1013-2024 |
BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susce… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1012-2024 |
BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitativ… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2024-01-08 |
Class II
|
Ongoing |
Z-1011-2024 |
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-q… |
— |
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis… |
| 2023-11-16 |
Class II
|
Ongoing |
Z-0736-2024 |
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number … |
— |
An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled … |
| 2023-10-11 |
Class II
|
Ongoing |
Z-0351-2024 |
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bond… |
— |
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). |
| 2023-10-11 |
Class II
|
Ongoing |
Z-0350-2024 |
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW AB… |
— |
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). |
| 2023-10-11 |
Class II
|
Ongoing |
Z-0349-2024 |
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore… |
— |
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). |
| 2023-09-12 |
Class II
|
Ongoing |
Z-0110-2024 |
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 |
— |
Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than on… |
| 2023-06-08 |
Class II
|
Ongoing |
Z-2099-2023 |
BD Synapsys Informatics Solution, Catalog Number 444150 |
— |
There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operatin… |
| 2023-05-01 |
Class II
|
Ongoing |
Z-1682-2023 |
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, s… |
— |
IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,spec… |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1415-2023 |
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform.… |
— |
Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after… |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1244-2023 |
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatmen… |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1243-2023 |
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment … |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1242-2023 |
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed … |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1241-2023 |
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of … |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1240-2023 |
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment o… |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1239-2023 |
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed f… |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1238-2023 |
BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are design… |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1237-2023 |
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment… |
— |
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| 2022-11-21 |
Class II
|
Ongoing |
Z-0473-2023 |
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267 |
— |
Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus gro… |
| 2022-10-13 |
Class II
|
Ongoing |
Z-0232-2023 |
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerob… |
— |
Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) … |
| 2022-09-15 |
Class II
|
Ongoing |
Z-0095-2023 |
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transportin… |
— |
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The… |
| 2022-07-18 |
Class II
|
Ongoing |
Z-1555-2022 |
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically… |
— |
Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product. |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1441-2022 |
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1440-2022 |
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1439-2022 |
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1438-2022 |
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1437-2022 |
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1436-2022 |
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1435-2022 |
BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1434-2022 |
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1433-2022 |
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1432-2022 |
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-05-09 |
Class II
|
Ongoing |
Z-1431-2022 |
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US) |
— |
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazar… |
| 2022-03-09 |
Class II
|
Terminated |
Z-1018-2022 |
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 |
— |
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic c… |
| 2022-01-06 |
Class III
|
Ongoing |
Z-0665-2022 |
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a ca… |
— |
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000… |
| 2022-01-05 |
Class II
|
Ongoing |
Z-0630-2022 |
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066 |
— |
May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is… |
| 2021-09-27 |
Class II
|
Terminated |
Z-0179-2022 |
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container cl… |
— |
Holes in product packaging impacts package integrity and may compromise sterility. |
| 2021-03-24 |
Class II
|
Terminated |
Z-1416-2021 |
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from th… |
— |
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A … |
| 2021-03-17 |
Class II
|
Terminated |
Z-1378-2021 |
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing … |
— |
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubati… |
| 2021-03-17 |
Class II
|
Terminated |
Z-1377-2021 |
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens contain… |
— |
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubati… |
| 2021-01-07 |
Class II
|
Terminated |
Z-0954-2021 |
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents… |
— |
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containi… |
| 2020-12-23 |
Class II
|
Terminated |
Z-1109-2021 |
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 |
— |
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility … |
| 2020-12-09 |
Class II
|
Terminated |
Z-0924-2021 |
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia … |
— |
BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications |
| 2020-12-09 |
Class II
|
Terminated |
Z-0923-2021 |
BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia… |
— |
BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications |
| 2020-12-08 |
Class II
|
Terminated |
Z-0766-2021 |
BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure cul… |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0765-2021 |
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure cu… |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0764-2021 |
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure … |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0763-2021 |
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure cul… |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0762-2021 |
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure … |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0761-2021 |
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure cul… |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0760-2021 |
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure … |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-12-08 |
Class II
|
Terminated |
Z-0759-2021 |
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure … |
— |
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred ant… |
| 2020-11-18 |
Class II
|
Terminated |
Z-0588-2021 |
BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and a… |
— |
BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present … |
| 2020-10-23 |
Class II
|
Terminated |
Z-0508-2021 |
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained… |
— |
Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needl… |
| 2020-09-14 |
Class II
|
Terminated |
Z-0295-2021 |
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intrave… |
— |
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit. |
| 2020-09-14 |
Class II
|
Terminated |
Z-0294-2021 |
Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intrav… |
— |
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit. |
| 2020-09-14 |
Class II
|
Terminated |
Z-0125-2021 |
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV cathete… |
— |
Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted |
| 2020-07-28 |
Class II
|
Terminated |
Z-2889-2020 |
BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack |
— |
Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, … |
| 2020-07-20 |
Class II
|
Terminated |
Z-2754-2020 |
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage… |
— |
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False … |
| 2020-06-19 |
Class II
|
Terminated |
Z-2671-2020 |
SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 008… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2670-2020 |
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), … |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2669-2020 |
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 008… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2668-2020 |
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2667-2020 |
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892) |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2666-2020 |
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499),… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2665-2020 |
SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 0080174… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2664-2020 |
SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2663-2020 |
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numb… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2662-2020 |
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2661-2020 |
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA000… |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-06-19 |
Class II
|
Terminated |
Z-2660-2020 |
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), … |
— |
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage re… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2065-2020 |
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535 |
— |
This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. |
| 2020-04-14 |
Class II
|
Terminated |
Z-2048-2020 |
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 -… |
— |
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a fals… |
| 2020-04-14 |
Class II
|
Terminated |
Z-2047-2020 |
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usag… |
— |
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a fals… |
| 2020-04-14 |
Class II
|
Terminated |
Z-2046-2020 |
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usa… |
— |
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a fals… |
| 2020-03-26 |
Class II
|
Terminated |
Z-1795-2020 |
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI N… |
— |
The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. |
| 2020-03-17 |
Class II
|
Terminated |
Z-1946-2020 |
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D |
— |
Iincorrectly packaged without the required lidocaine as labeled |
| 2020-02-26 |
Class II
|
Terminated |
Z-2082-2020 |
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435 |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2081-2020 |
BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2080-2020 |
BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2079-2020 |
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278 |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2078-2020 |
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277 |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2077-2020 |
BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276 |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2076-2020 |
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |
| 2020-02-26 |
Class II
|
Terminated |
Z-2075-2020 |
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025 |
— |
The kits contain surgical gowns which were subject to a recall by the supplier. |