Baxter Healthcare Corporation Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI 07332414007881, All lots within expiry
Products Sold
UDI 07332414007881, All lots within expiry
Baxter Healthcare Corporation is recalling Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for sin due to complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026