Recall Z-2379-2021— Baxter Healthcare Corporation
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-07-22, terminated 2024-01-17. It names one FDA 510(k) clearance: K042938. Product: Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.. 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.
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-22
- Terminated
- 2024-01-17
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.