| 2026-05-12 |
Class II
|
Ongoing |
Z-2321-2026 |
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; |
— |
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurr… |
| 2026-05-07 |
Class II
|
Ongoing |
Z-2401-2026 |
Bicarby Dialysate; Model number: RFP-400-G; |
— |
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctl… |
| 2025-10-25 |
Class II
|
Ongoing |
Z-0936-2026 |
5008X CAREsystem +CLiC +CDX; |
— |
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditio… |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0041-2026 |
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFL… |
— |
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version w… |
| 2025-04-29 |
Class II
|
Ongoing |
Z-1992-2025 |
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,… |
— |
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltratio… |
| 2024-12-05 |
Class II
|
Ongoing |
Z-0801-2025 |
Dialyzer Optiflux 160NRe |
— |
Potential for internal blood leaks due to cracked polyurethane |
| 2024-08-08 |
Class II
|
Ongoing |
Z-3124-2024 |
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S… |
— |
Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and … |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2347-2024 |
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2346-2024 |
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2345-2024 |
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2344-2024 |
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2343-2024 |
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2342-2024 |
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2341-2024 |
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2340-2024 |
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-05-16 |
Class II
|
Ongoing |
Z-2141-2024 |
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:… |
— |
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate … |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1870-2024 |
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1869-2024 |
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1868-2024 |
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1867-2024 |
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-04-17 |
Class II
|
Ongoing |
Z-1866-2024 |
Blood Pump Rotor, Model Number: F40015481 Rev A |
— |
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sh… |
| 2024-04-08 |
Class II
|
Ongoing |
Z-1822-2024 |
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ … |
— |
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) a… |
| 2024-01-23 |
Class I
|
Ongoing |
Z-1327-2024 |
stay-safe /Luer Catheter Ext. 6 in |
— |
The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| 2024-01-23 |
Class I
|
Ongoing |
Z-1326-2024 |
stay-safe /Luer Lock Catheter Ext. 18 in |
— |
The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| 2024-01-23 |
Class I
|
Ongoing |
Z-1325-2024 |
stay-safe /Luer Lock Catheter Ext. 12 in |
— |
The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| 2024-01-23 |
Class I
|
Ongoing |
Z-1324-2024 |
stay-safe /Luer Lock Adapter 4 in |
— |
The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| 2024-01-23 |
Class I
|
Ongoing |
Z-1323-2024 |
stay-safe /Safe Lock Catheter Ext. 12 in |
— |
The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| 2023-10-24 |
Class III
|
Ongoing |
Z-0619-2024 |
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 |
— |
Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. |
| 2023-10-10 |
Class II
|
Ongoing |
Z-0507-2024 |
Stay Safe Cap |
— |
Updating the labeling to include additional warnings and contraindications for potential side effects. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0035-2024 |
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0034-2024 |
2008T HD SYS. W/O CDX BLUESTAR |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0033-2024 |
2008T HD SYS. CDX W/BIBAG BLUESTAR |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0032-2024 |
2008T HD SYS. CDX BLUESTAR |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0031-2024 |
2008T GEN 2 Bibag without CDX |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0030-2024 |
2008T Hemodialysis System w/Bibag |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0029-2024 |
2008T Hemodialysis System without CDX |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-09-06 |
Class I
|
Ongoing |
Z-0028-2024 |
2008T Hemodialysis SYS, with CDX |
— |
Potential PCBA leaching from tubing of hemodialysis machines. |
| 2023-08-08 |
Class I
|
Ongoing |
Z-0007-2024 |
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case |
— |
There is a potential for blood backfill leakage and foreign material. |
| 2023-08-08 |
Class I
|
Ongoing |
Z-0006-2024 |
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case |
— |
There is a potential for blood backfill leakage and foreign material. |
| 2023-08-08 |
Class I
|
Ongoing |
Z-0005-2024 |
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case |
— |
There is a potential for blood backfill leakage and foreign material. |
| 2022-10-04 |
Class II
|
Ongoing |
Z-0181-2023 |
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis. |
— |
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium ch… |
| 2022-07-27 |
Class II
|
Ongoing |
Z-0734-2023 |
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare… |
— |
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electrom… |
| 2022-06-21 |
Class II
|
Ongoing |
Z-1770-2022 |
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresen… |
— |
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 2022-06-21 |
Class II
|
Ongoing |
Z-1769-2022 |
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fre… |
— |
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1464-2022 |
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US |
— |
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet ca… |
| 2022-06-16 |
Class II
|
Ongoing |
Z-1463-2022 |
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US |
— |
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet ca… |
| 2022-06-01 |
Class II
|
Terminated |
Z-1311-2022 |
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 |
— |
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contaminatio… |
| 2022-05-31 |
Class II
|
Ongoing |
Z-1371-2022 |
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for … |
— |
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use |
| 2022-05-31 |
Class II
|
Ongoing |
Z-1370-2022 |
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for … |
— |
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use |
| 2022-05-04 |
Class II
|
Terminated |
Z-1303-2022 |
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E |
— |
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. |
| 2021-12-07 |
Class II
|
Ongoing |
Z-0562-2022 |
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respir… |
— |
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor… |
| 2021-08-03 |
Class II
|
Terminated |
Z-1364-2022 |
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Ty… |
— |
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may b… |
| 2021-04-28 |
Class II
|
Terminated |
Z-2090-2021 |
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equiva… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2089-2021 |
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/discon… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2088-2021 |
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2087-2021 |
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the prep… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2086-2021 |
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component i… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2085-2021 |
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in h… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2084-2021 |
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the pr… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2083-2021 |
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-04-28 |
Class II
|
Terminated |
Z-2082-2021 |
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients wit… |
— |
Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2021-03-18 |
Class II
|
Terminated |
Z-1536-2021 |
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to rem… |
— |
AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may b… |
| 2020-12-17 |
Class II
|
Terminated |
Z-0942-2021 |
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Numb… |
— |
Bottles Missing Product Label |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0841-2021 |
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Re… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0840-2021 |
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Ren… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0839-2021 |
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Ren… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0838-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0837-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0836-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0835-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0834-2021 |
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0833-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0832-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0831-2021 |
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius R… |
— |
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions tha… |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0829-2021 |
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Ren… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0828-2021 |
Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Ren… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0827-2021 |
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0826-2021 |
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Ren… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0825-2021 |
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Ren… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0824-2021 |
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Ren… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0823-2021 |
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Ren… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0822-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0821-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0820-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius R… |
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The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0819-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius R… |
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The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0818-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0817-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0816-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0815-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0814-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0813-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0812-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-11-07 |
Class II
|
Ongoing |
Z-0811-2021 |
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius R… |
— |
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| 2020-09-12 |
Class II
|
Completed |
Z-0439-2021 |
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 |
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The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag t… |
| 2020-09-01 |
Class II
|
Terminated |
Z-0098-2021 |
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorgani… |
— |
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, the… |
| 2020-03-12 |
Class II
|
Ongoing |
Z-1749-2020 |
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2… |
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A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine |
| 2020-03-12 |
Class II
|
Ongoing |
Z-1748-2020 |
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 19071… |
— |
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine |
| 2020-01-29 |
Class II
|
Terminated |
Z-1529-2020 |
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delive… |
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The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part. |