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.
Enforcement
- Recall Number
- Z-2018-2012
- Event ID
- 62451
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Kimberly-Clark Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 25, 2012
- Initiation Date
- September 17, 2009
- Classification Date
- July 16, 2012
- Termination Date
- July 19, 2012
- Address
- 1400 Holcomb Bridge Rd, Roswell, GA, 30076, United States
Description
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.
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
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.
Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA