Z-2379-2021 Class II Terminated
FDA device recall Z-2379-2021 was initiated by Baxter Healthcare Corporation on Jul 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… The recall status is terminated (terminated Jan 17, 2024). Affected quantity: 1976 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 8, 2021
- Initiation Date
- Jul 22, 2021
- Termination Date
- Jan 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2379-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026