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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-0734-2016

November 17, 2015

Class II

Product summary

Firm
Owens & Minor Distribution, Inc.
Event
Event 72910
Status
Terminated
Classification
Class II
Quantity
96266
Official record key
device-enforcement:Z-0734-2016

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: CBN1104 15023H09A Jan-18, CBN1104 15033H09A Feb-18, CBN1104 15043H09A Mar-18, CBN1104 15053H09A Apr-18, CBN1104 15063H09A May-18, CBN1104 15073H09A Jun-18, CBN1104 15083H09A Jul-18, CBN1104 14113H09A Oct-17, CBN1104 14123H09A Nov-17, CBN1104 15013H09A Dec-17, CBN1104 14063H09A May-17, CBN1104 14083H09A Jul-17, CBN1104 14093H09A Aug-17, CBN1104 14053H09A Apr-17, CBN1104 14043H09A Mar-17, CBN1104 14013H09A Dec-16, CBN1104 13053H09A Apr-16, CBN1104 12113H09A Oct-15, CBN1104 13033H09A Feb-16, CBN1104 13083H09A Jul-16, CBN1104 13083H09A Jul-16, CBN1104 13103H09A Sep-16, CBN1104 13113H09A Oct-16, CBN1104 13123H09A Nov-16.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination