2008T HD SYS. CDX BLUESTAR
FDA device recall Z-0032-2024 · posted 2023-10-06 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Potential PCBA leaching from tubing of hemodialysis machines.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 733 units
- Distribution
- Domestic: Nationwide Distribution.
- Date initiated
- 2023-09-06
- Date posted
- 2023-10-06
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2008T BlueStar Hemodailysis Machine (K222952) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 |
| 2008T BlueStar Hemodialysis Machine (K173972) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 |
| 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (K150708) | Fresenius Medical Care Renal Therapies Group, LLC | 2015-12-10 |