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.
This recall has been terminated (originally issued July 16, 2012).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- September 17, 2009
- Posted
- July 16, 2012
- Terminated
- July 19, 2012
- Recall Number
- Z-2018-2012
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Distribution
Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.