RecallRadar

FDA Device recall Z-0995-2013

KIMGUARD Container Filters, 7.5in (19cm), Round and 9in

On 2013-04-03 the FDA classified a Class II recall of KIMGUARD Container Filters, 7.5in (19cm), Round and 9in by Kimberly Clark, citing some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0995-2013
ClassificationClass II
Statusterminated
Initiated2013-03-06
Published2013-04-03
Last updated2026-09-13 11:53 UTC
CompanyKimberly Clark
DistributionAK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI

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.

Identifiers

code_info
Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX…Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX. Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0995-2013%22

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