Date Initiated by Firm |
July 05, 2012 |
Date Posted |
November 07, 2012 |
Recall Status1 |
Terminated 3 on June 13, 2013 |
Recall Number |
Z-0257-2013 |
Recall Event ID |
63598 |
510(K)Number |
K842115 K103406
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Product Classification |
Drape, surgical - Product Code KKX
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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 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 |
89,856 (28 units per case) |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KKX and Original Applicant = KIMBERLY-CLARK CORP.
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