Baxter Healthcare Corporation Recall 91223
Description: Revaclear 400 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-0763-2023 |
| Event ID | 91223 |
| Event Description | Revaclear 400 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 | 6,338,280 units |
| Recall Reason | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| Device Classification | 20221228 |
| Device Code Info | a. UDI-DI: 07332414124076; Product Code: 114746L; All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209; Product Code: 114746M; All lot numbers from C422218601-C422219901 |
| Center Classification Date | 20221222 |
| Recall Initiation Date | 20221123 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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