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U.S. Department of Health and Human Services

Class 3 Device Recall ULTRA Fabric Reinforced Surgical Gown

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  Class 3 Device Recall ULTRA Fabric Reinforced Surgical Gown see related information
Date Initiated by Firm December 31, 2010
Date Posted September 20, 2012
Recall Status1 Terminated 3 on November 01, 2012
Recall Number Z-2425-2012
Recall Event ID 62577
Product Classification Drape, surgical - Product Code KKX
Product ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File.

The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown 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: 95221-35, Unit Code: 90372
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		 The impacted product was not intended for commercial distribution to end users.
FDA Determined
Cause 2		 Packaging process control
Action Kimberly-Clark sent a Urgent Medical Recall Notice dated on December 31, 2010. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to: Evaluate their Distribution Facilities Inventory of Ultra Fabric Reinforced surgical Gown to determine if any of impacted product remained within their facility. If present, to discontinue distribution of the impacted product and place in a quarantined location. Complete the attached Distributor Product Withdrawal Response Form and fax it to KC within five days. Destroy the impacted product according to their facility procedures. And to review their distribution records to identify all customers who were shipped any of the impacted products. Notify each of their customers who were shipped any of the impacted products by sending them a copy of the attached Customer Letter with the Customer Withdrawal Response Form. A minimum of three (3) attempts to contact each non-responding customer within interval of approximately four to six weeks will be performed. Once all customers who were notified have responded or after approximately four weeks after the third attempt to contact the last non-responder, a recall Termination will be initiated If your Kimberly-Clark Representative has not already contacted you, please contact the Ultra Fabric Reinforce surgical Gown Coordinator at (770) - 587-7700.
Quantity in Commerce 32 cases
Distribution US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
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.
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