Device product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Z-2379-2021
Product summary
- Event
- Event 88351
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1976 units
- Official record key
device-enforcement:Z-2379-2021
Official wording
Reason: 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
Code information: Lot Numbers: 20B2330M
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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