Class 2 Device Recall MicroCool Breathable Impervious Gown with Secure Fit Surgical,

• Date Initiated by Firm: September 17, 2009
• Date Posted: July 16, 2012
• Recall Status: Terminated on July 19, 2012
• Recall Number: Z-2018-2012
• Recall Event ID: 62451
• 510(K)Number: K091357
• Product Classification: Gown, surgical - Product Code FYA
• Product: MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), 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: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173.
• 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: 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.
• 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.