Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
FDA Recall Z-2379-2021 · Posted None
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDI
Date Initiated2021-07-22
Date Terminated2024-01-17
Product Quantity1976 units
Reason for Recall
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming
Firm Action
The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.
Root Cause
Vendor change control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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