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Open, Classified

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

FDA Recall Z-0764-2023 · Posted 2022-12-22

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2022-11-23
Product Quantity1,140,096 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERGambro Renal Products, Inc. · 2013-05-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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