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U.S. Department of Health and Human Services

Class 2 Device Recall Kimberly Clark Ultra Surgical Gown

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  Class 2 Device Recall Kimberly Clark Ultra Surgical Gown see related information
Date Initiated by Firm December 23, 2010
Date Posted January 18, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-0921-2011
Recall Event ID 57535
Product Classification Surgical Gown - Product Code FYA
Product Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras.
Code Information Product code (Extra Large Surgical Gowns): 95121-35, Case Lot Numbers: AH0319YL3, AH0320YNF, AH0320YNB, AH0320YNA, AH0320YNG; Individual Unit Lot Numbers (printed on the sterile pouch): AH0319A, AH0319B, AH0319C, AH0320A, AH0320B, AH0320C.
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		 Product was not properly sterilized.
FDA Determined
Cause 2		 Pending
Action Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and 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 Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm's Recall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.
Quantity in Commerce 40 cases (32 units per case)
Distribution Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
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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