Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Summary
The FDA issued a Class II for Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal by Baxter Healthcare Corporation. Reason: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak.
Details
Source
Device Recall
External ID
Z-0762-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Lot/Code Info: UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401
Quantity Affected: 14,053,824 units
Reason for Recall
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-23
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0762-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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