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U.S. Department of Health and Human Services

Class 2 Device Recall ULTRA Fabric Reinforced surgical Gown XLarge Sterile

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 Class 2 Recall
ULTRA Fabric Reinforced surgical Gown XLarge Sterile
see related information
Date Posted November 07, 2012
Recall Status1 Terminated on June 13, 2013
Recall Number Z-0257-2013
Recall Event ID 63598
Premarket Notification
510(K) Number
K842115 
Product Classification Drape, Surgical - Product Code KKX
Product ULTRA Fabric Reinforced surgical Gown X-Large 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 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
Recalling Firm/
Manufacturer
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell, Georgia 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
PRODUCTION CONTROLS: 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 89,856 (28 units per case)
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KKX and Original Applicant = KIMBERLY-CLARK CORP.
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