FDAFDA · Food and drugs·Recall number Z-2379-2021
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Published September 8, 2021 · Recall initiated: July 22, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide distribution.
- Lot
- Lot Numbers: 20B2330M
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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