Z-0474-2016Class II

Enterococcus Screen Agar QUAD Plate

Name: Z-0474-2016 Enterococcus Screen Agar QUAD Plate
Creator: Becton Dickinson & Co.
Published: 2015-06-29
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-06-29 / Terminated

FDA source

Becton Dickinson & Co. began a recall of Enterococcus Screen Agar QUAD Plate on 2015-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0474-2016
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Posted: 2015-12-23
Terminated: 2016-08-12
Recalling firm: Becton Dickinson & Co
Product: Enterococcus Screen Agar QUAD Plate
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 770
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.
Product codes and lots: catalog number 222201. Lot numbers 5064938, 5085954, 5105509, and 5133580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0474-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23
Z-0474-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code JWY

K951539Class IIEnterococcus Screening MediumBecton Dickinson Microbiology Systems / cleared 1995-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)