Recall Z-1122-2021— Baxter Healthcare Corporation

Name: FDA recall Z-1122-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-30

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-12-30. It names one FDA 510(k) clearance: K070414. 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.. Reason: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-12-30
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K070414 — GAMBRO CARTRIDGE BLOOD SETSGambro Renal Products·cleared 2007-10-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.