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Recall Observatory FDA recall evidence

Device product

BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.

Z-1799-2013

June 06, 2013

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 65614
Status
Terminated
Classification
Class II
Quantity
92 cartons
Official record key
device-enforcement:Z-1799-2013

Official wording

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

Code information: Lot 3078263 Exp 5/16/13

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.