Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA device recall Z-0764-2023 · posted 2022-12-22 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 1,140,096 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, U
- Date initiated
- 2022-11-23
- Date posted
- 2022-12-22
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (K130039) | Gambro Renal Products, Inc. | 2013-05-02 |