PlainRecalls
FDA Devices Moderate Class II Terminated

Vancomycin Screen Agar

Reported: December 30, 2015 Initiated: June 29, 2015 #Z-0473-2016

Product Description

Vancomycin Screen Agar

Reason for Recall

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.

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
60,840
Distribution
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.
Location
Sparks, MD

Frequently Asked Questions

What product was recalled?
Vancomycin Screen Agar. Recalled by Becton Dickinson & Co.. Units affected: 60,840.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0473-2016.