MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, 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.
FDA Recall Z-2017-2012 · Posted 2012-07-16
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Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeFYA
Date Initiated2009-09-17
Date Terminated2012-07-19
Product Quantity79,941 units
Reason for Recall
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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