Z-1684-2021 Class II Terminated
FDA device recall Z-1684-2021 was initiated by Baxter Healthcare Corporation on Apr 14, 2021 and is designated Class II. Reason for recall: There is a potential leak between the venous patient connector and patient's hemodialysis access. The recall status is terminated (terminated May 10, 2024). Affected quantity: 17,487 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 2, 2021
- Initiation Date
- Apr 14, 2021
- Termination Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,487 units
Product description
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason for recall
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Distribution pattern
Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Code information
Product Code: 101025; Lot 1000276191, UDI: 37332414007837
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1684-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026