Z-0474-2016 Class II Terminated
FDA device recall Z-0474-2016 was initiated by Becton Dickinson & Co. on Jun 29, 2015 and is designated Class II. 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… The recall status is terminated (terminated Aug 12, 2016). Affected quantity: 770.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 30, 2015
- Initiation Date
- Jun 29, 2015
- Termination Date
- Aug 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 770
Product Description
Enterococcus Screen Agar QUAD Plate
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.
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.
Code Information
catalog number 222201. Lot numbers 5064938, 5085954, 5105509, and 5133580
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0474-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026