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U.S. Department of Health and Human Services

Class 2 Device Recall KimberlyClark KIMGUARD Container Filters

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  Class 2 Device Recall KimberlyClark KIMGUARD Container Filters see related information
Date Initiated by Firm March 06, 2013
Date Posting Updated March 26, 2013
Recall Status1 Terminated 3 on September 16, 2013
Recall Number Z-0995-2013
Recall Event ID 64689
510(K)Number K881471  
Product Classification Wrap, sterilization - Product Code FRG
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.
Code Information 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.
Recalling Firm/
Manufacturer
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact Thomas Kozma, PhD
770-587-8393
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRG and Original Applicant = KIMBERLY-CLARK CORP.
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