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U.S. Department of Health and Human Services

Class 2 Device Recall MicroCool Breathable Gown with Towels

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  Class 2 Device Recall MicroCool Breathable Gown with Towels see related information
Date Initiated by Firm July 05, 2012
Date Posting Updated November 07, 2012
Recall Status1 Terminated 3 on June 13, 2013
Recall Number Z-0258-2013
Recall Event ID 63598
510(K)Number K103406  
Product Classification Gown, surgical - Product Code FYA
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.
Code Information Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***
Recalling Firm/
Manufacturer
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact Thomas Kozma, PhD
770-587-7835
Manufacturer Reason
for Recall
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
FDA Determined
Cause 2
Packaging process control
Action Kimberly Clark sent an Urgent Voluntary Product Recall letter dated July 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to determine if they have any affected product in their inventory. Any affected product should be quarantined and distribution discontinued. Distributors were also asked to conduct a sub-recall for any affected product further distributed. Customers were asked to complete the attached Distributor Product Recall Response Form and fax to 1-920-225-3522. Upon completion of the response form customers were asked to destroy any affected product. For questions regarding this recall call 770-587-7835.
Quantity in Commerce 933 ((30 units per case)
Distribution Nationwide Distribution
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 = FYA and Original Applicant = KIMBERLY-CLARK CORP.
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