Enterococcus Screen Agar QUAD Plate
FDA Recall Z-0474-2016 · Posted 2015-12-23
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJWY
Date Initiated2015-06-29
Date Terminated2016-08-12
Product Quantity770
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.
Firm Action
Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS.
Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility.
The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter.
Any product returned to BD will be quarantined and discarded.
If further assistance is needed, please contact BD Technical Services at 1-800-638-8663.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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