Recall Z-0762-2023
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 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Codes / lots: UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401
Reason for recall
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
FDA-determined cause: Process control
Action taken
Baxter Healthcare notified healthcare facilities on 11/23/2022 and home patients on 11/29/2022, via first class mail. Consignees were instructed to be aware of the difference in appearances between Polyurethane Displacement and an Internal Blood Leak and ensure staff is also aware. Additionally, consignees were instructed that if there is a blood leak alarm, to follow your clinical practice to stop treatment, and if only the Polyurethane Displacement is observed, to continue use of the dialyzer. Consignees were asked to acknowledge receipt of the notification by completing and returning the response form.
Details
- Recall number
- Z-0762-2023
- Initiated
- November 23, 2022
- Posted by FDA
- December 22, 2022
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Quantity
- 14,053,824 units
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0763-2023 Class II | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by…Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | 11/23/2022Open, Classified |
| Z-0764-2023 Class II | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by…Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | 11/23/2022Open, Classified |