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U.S. Department of Health and Human Services

Class 2 Device Recall MicroCool Breathable Impervious Surgical Gown

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  Class 2 Device Recall MicroCool Breathable Impervious Surgical Gown see related information
Date Initiated by Firm September 17, 2009
Date Posted July 16, 2012
Recall Status1 Terminated 3 on July 19, 2012
Recall Number Z-2017-2012
Recall Event ID 62451
510(K)Number K091357  
Product Classification Gown, surgical - Product Code FYA
Product MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras.

The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Code Information Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx. 
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact
770-587-7835
Manufacturer Reason
for Recall		 Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
FDA Determined
Cause 2		 Process control
Action Kimberly Clark sent an Urgent Medical Device Recall letter dated September 17, 2009. to all affected consignees. The Recall notification of the expanded recall was sent to consignees on November 17, 2009. Customers were instructed to destroy all affected product remaining in their inventory. For questions regarding this recall call 770-587-7400.
Quantity in Commerce 79,941 units
Distribution Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
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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