Baxter Healthcare Corporation recalls Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Use
Recalled Product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Hazard / Issue
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
Issued by
FDA
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