Recall Z-0761-2023
Baxter Healthcare Corporation · initiated November 23, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Codes / lots: Not distributed in the USA. Product Code: 114749M; Lot Numbers: C422202401, C422202501, C422202601, C422202701, C422202801, C422202901, C422203001, C422203101, C422203201, C422203301, C422203401, C422203501, C422203601, C422203701, C422203801, C422203901, C422204001, C422204101, C422204201, C422204301, C422204401, C422204501, C422204701.
Reason for recall
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
FDA-determined cause: Process change control
Action taken
Baxter Healthcare sent a notification via USPS first class mail on about 11/23/2022 and to home patients on about 11/29/2022. Consignees were instructed to locate and remove all affected product from your inventory, contact Baxter Healthcare Center for Service to arrange for return and credit, and acknowledge the receipt of the notification by completing a reply form on the customer portal. Note: this letter describes two issues. This recall addresses Internal Blood Leaks being caused by a twisted gasket in the dialyzer. The second issue is linked to reports of Polyurethane Displacement in the dialyzer, which is addressed in a separate recall.
Details
- Recall number
- Z-0761-2023
- Initiated
- November 23, 2022
- Posted by FDA
- December 22, 2022
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Quantity
- 449,544 units
- Distribution
- Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; 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, and Trinidad and Tobago.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0760-2023 Class II | Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal…Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | 11/23/2022Open, Classified |