Z-0761-2023 Class II Ongoing
FDA device recall Z-0761-2023 was initiated by Baxter Healthcare Corporation on Nov 23, 2022 and is designated Class II. Reason for recall: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer The recall status is ongoing. Affected quantity: 449,544 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2022
- Initiation Date
- Nov 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 449,544 units
Product Description
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Reason for Recall
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0761-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026