Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- December 30, 2020
- Recall Number
- Z-1123-2021
- Quantity
- 25785 devices
- Firm Location
- Deerfield, IL
Reason for Recall
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Distribution
Worldwide distribution.
Lot / Code Info
UDI 07332414112400, All lots within expiry
Root Cause
Under Investigation by firm
Action Taken
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.
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