Z-1798-2013Class II

BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson...

Name: Z-1798-2013 BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson...
Creator: Becton Dickinson & Co.
Published: 2013-06-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-06-06 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA... on 2013-06-06. FDA classified it as Class II and gives the reason as "Microbiological identification media may exhibit reduced levels of Vancomycin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1798-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Posted: 2013-07-24
Terminated: 2013-09-03
Recalling firm: Becton Dickinson & Co
Product: BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Microbiological identification media may exhibit reduced levels of Vancomycin.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to contact BD by telephone to receive replacements. If you have any questions, call 410-316-4000.
Quantity in commerce: 911 cartons
Distribution: Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Product codes and lots: Lot 3081136 Exp June 18, 2013 Lot 3073114 Exp June 12, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1798-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1798-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1799-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1800-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1801-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1802-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1803-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1804-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24
Z-1805-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24

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)