Z-0995-2013Class II

KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to...

Name: Z-0995-2013 KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to...
Creator: Kimberly-Clark Corporation
Published: 2013-03-06
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2013-03-06 / Terminated / root cause: design

FDA source

Kimberly-Clark Corporation began a recall of 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... on 2013-03-06. FDA classified it as Class II and gives the reason as "Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0995-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-03-26
Terminated: 2013-09-16
Recalling firm: Kimberly-Clark Corporation
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.
Product code: FRG Wrap, Sterilization
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: All US distributors and clinics were sent an Urgent: Voluntary Product Recall letter via Federal Express, and the Canadian importer/distributor was also notified with the same letter via Federal Express and e-mail. Distributors were instructed to contact their customers by sending a copy of the letter. The letter identified the affected product and stated the reason for the recall. The recall notification includes a Response Sheet that allows the customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The customer is instructed to immediately cease further distribution of the product, physically quarantine and destroy the product, and fax the completed Response Sheet to the Kimberly-Clark Recall Coordinator.
Quantity in commerce: Code 68507 - 6420 cases; Code 68509 - 1281 cases
Distribution: Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-26

Product code FRG

K881471Class IIKimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. / cleared 1988-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)