Vancomycin Screen Agar

FDA device recall Z-0473-2016 · posted 2015-12-23 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

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.

Action taken

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

Status

Terminated

Product code

JWY

Quantity 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,

Date initiated

2015-06-29

Date posted

2015-12-23

Date terminated

2016-08-12

Location

Sparks, MD

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