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Open, Classified

Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

FDA Recall Z-1118-2021 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFJK
Date Initiated2020-12-30
Product Quantity7437480 units

Reason for Recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070414GAMBRO CARTRIDGE BLOOD SETSGambro Renal Products · 2007-10-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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