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Recall Observatory FDA recall evidence

Device product

BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.

Z-1800-2013

June 06, 2013

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 65614
Status
Terminated
Classification
Class II
Quantity
45 cartons
Official record key
device-enforcement:Z-1800-2013

Official wording

Reason: Microbiological identification media may exhibit reduced levels of Vancomycin.

Code information: Lot 3080083 Exp 6/4/13 Lot 3073075 Exp 5/29/13

Distribution pattern: Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Microbiological identification media may exhibit reduced levels of Vancomycin.