Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
FDA device recall Z-0760-2023 · posted 2022-12-22 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 3,610,944 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 Af
- 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 |