Z-2379-2021 Class II Terminated
FDA device recall Z-2379-2021 was initiated by Baxter Healthcare Corporation on July 22, 2021 and is designated Class II. Reason for recall: 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 appea… The recall status is terminated (terminated January 17, 2024). Affected quantity: 1976 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- July 22, 2021
- Termination Date
- January 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1976 units
Product Description
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers: 20B2330M