Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- November 23, 2022
- Posted
- December 22, 2022
- Recall Number
- Z-0761-2023
- Quantity
- 449,544 units
- Firm Location
- Deerfield, IL
Reason for Recall
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
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.
Lot / Code Info
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.
Root 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.