2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Recall
- Recall Number
- Z-0035-2024
- Event Number
- 92788
- Firm
- Fresenius Medical Care Holdings, Inc.
- FEI Number
- 3001451489
- Product Code
- KDI
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- September 6, 2023
- Posted
- October 6, 2023
- Address
- 920 Winter St, Bld 920, Waltham, MA, 02451-1521
Description
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Potential PCBA leaching from tubing of hemodialysis machines.
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.
Domestic: Nationwide Distribution.
733 units