Recall Z-0080-2015— Baxter Healthcare Corp

Name: FDA recall Z-0080-2015
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp, initiated 2013-10-17, terminated 2016-01-04. It names one FDA 510(k) clearance: K791899. Product: 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.. Reason: The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage..

Recalling firm: Baxter Healthcare Corp
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Terminated: 2016-01-04
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

15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.

Reason for recall

The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

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