Z-1684-2021 Class II Terminated
FDA device recall Z-1684-2021 was initiated by Baxter Healthcare Corporation on April 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
- June 2, 2021
- Initiation Date
- April 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