Recall Z-0029-2024
Fresenius Medical Care Holdings, Inc. · initiated September 6, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
2008T Hemodialysis System without CDX
Codes / lots: Model No: 190858; UDI-DI: 00840861100903; Serial No. 1T0S261032, 1T0S261004, 1T0S261029, 1T0S260995, 1T0S260937, 1T0S260739, 1T0S260687, 1T0S260573, 2T0S263945, 2T0S263947, 2T0S263959, 2T0S263924, 2T0S263962, 2T0S263956, 2T0S263951, 2T0S263950, 2T0S263707, 2T0S263692, 2T0S263690, 2T0S263682, 2T0S263700, 2T0S264084, 2T0S263944, 2T0S263954, 2T0S263957, 2T0S264087, 2T0S264144, 2T0S264132, 2T0S264073, 2T0S264139, 2T0S264061, 2T0S263979, 2T0S263983, 2T0S263973, 2T0S263977, 2T0S263989, 2T0S263938, 2T0S263960, 2T0S263943, 2T0S263968, 2T0S263941, 2T0S263940, 2T0S263939, 2T0S263934, 2T0S263933, 2T0S263932, 2T0S263931, 2T0S263930, 2T0S263927, 2T0S263926, 2T0S263925, 2T0S263923, 2T0S263922, 2T0S263921, 2T0S263920, 2T0S263919, 2T0S263918, 2T0S263916, 2T0S263912, 2T0S263911, 2T0S263910, 2T0S263792, 2T0S263791, 2T0S263784, 2T0S263780, 2T0S263778, 2T0S263776, 2T0S263775, 2T0S263771, 2T0S263769, 2T0S263767, 2T0S263754, 2T0S263752, 2T0S263721, 2T0S263715, 2T0S263711, 2T0S263703, 2T0S263948, 2T0S263718, 2T0S263935, 2T0S263946, 2T0S263953, 2T0S263785, 2T0S263710, 2T0S263615, 2T0S264240, 2T0S264210, 2T0S264246, 2T0S264220, 2T0S264243, 2T0S264250, 2T0S264211, 2T0S264221, 2T0S264247, 2T0S264255…
Reason for recall
Potential PCBA leaching from tubing of hemodialysis machines.
FDA-determined cause: Device Design
Action taken
Consignees were sent an URGENT MEDICAL DEVICE CORRECTION NOTICE via USPS, dated 09/06/2023. The notice informed consignees that there is a potential for NDL-PCBAs could leach from silicone tubing manufactured with a peroxide-based catalyst. The firm also states that it has been demonstrated that dialysate run through 2008 Series machines used during typical maintenance HD treatments for at least 36 days, cumulatively, showed levels of NDL-PCBAs that were below toxicologically relevant thresholds. Consignees are to contact FMCRTG Technical Service at 1-800-227-2572 to schedule an update to devices to receive the correct tubing or if they have any further questions. Consignees with clinical questions are to contact Global Medical Information and Education Office at 1-855-2309. Consignees are to return the provided response form via fax or mail.
Details
- Recall number
- Z-0029-2024
- Initiated
- September 6, 2023
- Posted by FDA
- October 6, 2023
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Quantity
- 733 units
- Distribution
- Domestic: Nationwide Distribution.
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0028-2024 Class I | 2008T Hemodialysis SYS, with CDXPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |
| Z-0030-2024 Class I | 2008T Hemodialysis System w/BibagPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |
| Z-0031-2024 Class I | 2008T GEN 2 Bibag without CDXPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |
| Z-0032-2024 Class I | 2008T HD SYS. CDX BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |
| Z-0033-2024 Class I | 2008T HD SYS. CDX W/BIBAG BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |
| Z-0034-2024 Class I | 2008T HD SYS. W/O CDX BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |
| Z-0035-2024 Class I | 2008T HD SYS. W/O CDX W/BIBAG BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | 09/06/2023Open, Classified |