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

FDA device recall Z-0761-2023 · 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

449,544 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