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Recall Observatory FDA recall evidence

Device 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.

Z-2018-2012

September 17, 2009

Class II

Product summary

Firm
Kimberly-Clark Corporation
Event
Event 62451
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2018-2012

Official wording

Reason: Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

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.

Distribution pattern: Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.