MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Hondu...
FDA Recall #Z-2018-2012 — Class II — September 17, 2009
Product 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.
Reason for Recall
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Recalling Firm
Kimberly-Clark Corporation — Roswell, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated