Recall Z-0194-2016— Baxter Healthcare Corp.

Name: FDA recall Z-0194-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-06

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2015-10-06, terminated 2016-06-27. It names one FDA 510(k) clearance: K791899. Product: Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path. Reason: Leakage from the inlet port of the 15L Cycler Drainage Bags..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-10-06
Terminated: 2016-06-27
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K791899 — CYCLER SETS MOD. #5C4143, 5C4144, 5C4145Travenol Laboratories, S.A.·cleared 1979-11-13

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

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

Reason for recall

Leakage from the inlet port of the 15L Cycler Drainage Bags.

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