Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Reported: September 8, 2021 Initiated: July 22, 2021 #Z-2379-2021
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
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 1976 units
- Distribution
- US Nationwide distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.. Recalled by Baxter Healthcare Corporation. Units affected: 1976 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2379-2021.
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