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Recall Observatory FDA recall evidence

Device product

MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Z-0258-2013

July 05, 2012

Class II

Product summary

Firm
Kimberly-Clark Corporation
Event
Event 63598
Status
Terminated
Classification
Class II
Quantity
933 ((30 units per case)
Official record key
device-enforcement:Z-0258-2013

Official wording

Reason: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Code information: Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.