Baxter recalls Prismaflex HF 1000 PAES membrane (lot 20B2330M) due to potential unsterilized products affecting medical treatments. Affected users should contact Baxter for guidance.
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
Baxter is recalling a specific medical membrane used in dialysis equipment because some units may not have been properly sterilized. This could lead to infections or other complications during medical treatments.
The membrane may not have been properly sterilized, which could lead to infections or other complications during medical treatments. Baxter confirmed that sterilization data was manipulated to appear compliant, but the exact issue is unclear.
Healthcare facilities using Baxter's Prismaflex HF 1000 PAES membrane (lot 20B2330M) for dialysis treatments are most at risk. Patients using this membrane for renal replacement therapies may need to check their equipment.
Check for the lot number 20B2330M on the Baxter Prismaflex HF 1000 PAES membrane used with Prismaflex or PrisMax control units for dialysis treatments.
Look for the lot number 20B2330M on the membrane packaging.
Baxter confirmed that some units may not have been properly sterilized, and sterilization data was manipulated to appear compliant.
Contact Baxter directly for guidance on next steps, as the recall remedy is not specified in the record.
The recall indicates a potential risk of infection or complications during medical treatments, but the exact danger level is not clearly stated.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2379-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2379-2021 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
