FDA Recall
Terminated
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Recall: Z-1684-2021
·
Initiated April 14, 2021
Recall
- Recall Number
- Z-1684-2021
- Event Number
- 87739
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- FJK
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 14, 2021
- Terminated
- May 10, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
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
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Action
An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email.
Distribution
Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Quantity
17,487 units