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Open, Classified

2008T GEN 2 Bibag without CDX

FDA Recall Z-0031-2024 · Posted 2023-10-06

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2023-09-06
Product Quantity733 units

Reason for Recall

Potential PCBA leaching from tubing of hemodialysis machines.

Firm Action

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

Distribution Pattern

Domestic: Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022-10-27K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018-05-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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