Product Wiki · Recalls · U.S. FDA — Device Enforcement

Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. — recall Z-0762-2023

U.S. FDA — Device Enforcement · United States · 2022-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0762-2023
Date of alert
2022-11-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07332414123055
Reported risk: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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