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Recall Observatory FDA recall evidence

Device product

Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

Z-0808-2013

August 21, 2012

Class II

Product summary

Firm
Remel Inc
Event
Event 63556
Status
Terminated
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-0808-2013

Official wording

Reason: The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

Code information: Lot 1186069

Distribution pattern: US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.