—#197273

Product

Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected 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.

Why it was recalled

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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.

Timeline

Recall initiated: 2022-11-23
Posted by FDA: 2022-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197273. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.