Z-1802-2013Class II

BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog #...

Name: Z-1802-2013 BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog #...
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 BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and... 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-1802-2013
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 BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
Product code: JSI Culture Media, Selective And Differential
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: 42 cartons
Distribution: Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Product codes and lots: Lot 3071112 Exp 5/28/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1802-2013
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 JSI

K832955Class IBacteroides Bile Esculin AgarBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1983-09-29

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)