Recall Z-0258-2013— Kimberly-Clark Corporation

Name: FDA recall Z-0258-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-05

Class II · Terminated

Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2012-07-05, terminated 2013-06-13. It names one FDA 510(k) clearance: K103406. Product: MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.. Reason: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled..

Recalling firm: Kimberly-Clark Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-07-05
Terminated: 2013-06-13
Firm location: Roswell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K103406 — MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNSKimberly-Clark Corp.·cleared 2010-12-23

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

MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Reason for recall

Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

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