Recall Z-0411-2018— Baxter Healthcare Corporation

Name: FDA recall Z-0411-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-21

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2017-12-21, terminated 2020-08-04. It names one FDA 510(k) clearance: K133807. Product: MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541. Reason: Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-21
Terminated: 2020-08-04
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITGambro Renal Products, Inc.·cleared 2014-03-26

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

MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

Reason for recall

Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.

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