Recalls / —

—#197276

Product

Revaclear 400 dialyzers. Indicated for treatment of 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

510(k) numbers

K130039

Affected lot / code info

No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201

Why it was recalled

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Root cause (FDA determination)

Process control

Action the firm took

Baxter Healthcare notified healthcare facilities on 11/23/2022 and home patients on 11/29/2022, via first class mail. Consignees were instructed to be aware of the difference in appearances between Polyurethane Displacement and an Internal Blood Leak and ensure staff is also aware. Additionally, consignees were instructed that if there is a blood leak alarm, to follow your clinical practice to stop treatment, and if only the Polyurethane Displacement is observed, to continue use of the dialyzer. Consignees were asked to acknowledge receipt of the notification by completing and returning the response form.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of 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, St. Thomas, Trinidad and Tobago.

Timeline

Recall initiated

2022-11-23

Posted by FDA

2022-12-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.