Baxter Healthcare Corporation Recall 91223
Description: Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation Recall 91223 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0762-2023 |
Event ID | 91223 |
Event Description | Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago. |
Quantity | 14,053,824 units |
Recall Reason | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
Device Classification | 20221228 |
Device Code Info | UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401 |
Center Classification Date | 20221222 |
Recall Initiation Date | 20221123 |
Recalling Firm | Baxter Healthcare Corporation |
Initial Notification | Letter |
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