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FDAJuly 22, 2021device

Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

baxter healthcarebaxter

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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