Recalls / —
—#186887
Product
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- FDA product code
- FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K070414
- Affected lot / code info
- Product Code: 101025; Lot 1000276191, UDI: 37332414007837
Why it was recalled
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Timeline
- Recall initiated
- 2021-04-14
- Terminated
- 2024-05-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #186887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.