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Recall Observatory FDA recall evidence

Device product

Vancomycin Screen Agar

Z-0473-2016

June 29, 2015

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 71883
Status
Terminated
Classification
Class II
Quantity
60,840
Official record key
device-enforcement:Z-0473-2016

Official wording

Reason: The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

Code information: catalog number 222204. Lot numbers 5041659, 5064921, 5076659, 5083712, 5097504, 5105955, 5130907, 5139626, and 5147941

Distribution pattern: Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.