Recall Z-1010-2015— Baxter Healthcare Corp.

Name: FDA recall Z-1010-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-14

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2015-01-14, terminated 2017-04-10. It names one FDA 510(k) clearance: K960787. Product: Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m). Reason: Potential for failure of the pouch packaging seal at high altitudes..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-01-14
Terminated: 2017-04-10
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K960787 — TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSBaxter Healthcare Corp·cleared 1996-05-14

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

Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

Reason for recall

Potential for failure of the pouch packaging seal at high altitudes.

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