Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
FDA Recall Z-0760-2023 · Posted 2022-12-22
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Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2022-11-23
Product Quantity3,610,944 units
Reason for Recall
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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