Recall Z-0995-2013— Kimberly-Clark Corporation

Name: FDA recall Z-0995-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-06

Class II · Terminated

Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2013-03-06, terminated 2013-09-16. It names one FDA 510(k) clearance: K881471. Product: KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.. Reason: Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier..

Recalling firm: Kimberly-Clark Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Terminated: 2013-09-16
Firm location: Roswell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K881471 — KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAPKimberly-Clark Corp.·cleared 1988-08-10

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

KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.

Reason for recall

Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

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