Recall Z-1684-2021— Baxter Healthcare Corporation

Name: FDA recall Z-1684-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-14

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-04-14, terminated 2024-05-10. It names one FDA 510(k) clearance: K070414. Product: Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.. Reason: There is a potential leak between the venous patient connector and patient's hemodialysis access..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-04-14
Terminated: 2024-05-10
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 Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Reason for recall

There is a potential leak between the venous patient connector and patient's hemodialysis access.

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