Recalls / —
—#185443
Product
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - 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
- UDI 07332414112394, All lots within expiry
Why it was recalled
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The firm issued a Safety Alert on 12/30/2020 by mail. The letter explained the problem with photographs, and the hazard involved with using a device with a kinked line. Customers identifying set with kinked tubing may contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Distributor were asked to notify their customers by distributing the letter.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Worldwide distribution.
Timeline
- Recall initiated
- 2020-12-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #185443. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.