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Recall Observatory FDA recall evidence

Device product

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

Z-0735-2016

November 17, 2015

Class II

Product summary

Firm
Owens & Minor Distribution, Inc.
Event
Event 72910
Status
Terminated
Classification
Class II
Quantity
64011
Official record key
device-enforcement:Z-0735-2016

Official wording

Reason: MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.

Code information: Item No. Lot No. Expiration Date, CBN1106 12113H10A Oct-15, CBN1106 13033H10A Feb-16, CBN1106 13053H10A Apr-16, CBN1106 13083H10A Jul-16, CBN1106 13103H10A Sep-16, CBN1106 13113H10A Oct-16, CBN1106 14013H10A Dec-16, CBN1106 14043H10A Mar-17, CBN1106 14053H10A Apr-17, CBN1106 14063H10A May-17, CBN1106 14083H10A Jul-17, CBN1106 14093H10A Aug-17, CBN1106 14093H10A Aug-17, CBN1106 14113H10A Oct-17, CBN1106 14123H10A Nov-17, CBN1106 15013H10A Dec-17, CBN1106 15023H10A Jan-18, CBN1106 15033H10A Feb-18, CBN1106 15043H10A Mar-18, CBN1106 15053H10A Apr-18, CBN1106 15063H10A May-18, CBN1106 15083H10A Jul-18, CBN1106 15073H10A Jun-18.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination