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Recall Observatory FDA recall evidence

Device product

BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.

Z-1334-2013

March 11, 2013

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 64883
Status
Terminated
Classification
Class II
Quantity
521,160 total pieces (all three recalled products)
Official record key
device-enforcement:Z-1334-2013

Official wording

Reason: Microbiological media may be contaminated with bacteria.

Code information: Model number 221733: lot 2361003 with expiration date 3/14/13

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Microbiological media may be contaminated with bacteria.