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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-0733-2016

November 17, 2015

Class II

Product summary

Firm
Owens & Minor Distribution, Inc.
Event
Event 72910
Status
Terminated
Classification
Class II
Quantity
42,050
Official record key
device-enforcement:Z-0733-2016

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: CBN1103 12113H08A Oct-15, CBN1103 13033H08A Feb-16, CBN1103 13053H08A Apr-16, CBN1103 14013H08A Dec-16, CBN1103 14043H08A Mar-17, CBN1103 14053H08A Apr-17, CBN1103 14083H08A Jul-17, CBN1103 14063H08A May-17, CBN1103 15013H08A Dec-17, CBN1103 14123H08A Nov-17, CBN1103 14113H08A Oct-17, CBN1103 15023H08A Jan-18, CBN1103 15033H08A Feb-18, CBN1103 15043H08A Mar-18, CBN1103 15053H08A Apr-18, CBN1103 15063H08A May-18, CBN1103 15073H08A Jun-18, CBN1103 15083H08A Jul-18.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination