FDA Enforcement Class II Terminated

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.

Recall: Z-1802-2013 · Reported July 31, 2013

Enforcement

Recall Number
Z-1802-2013
Event ID
65614
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Becton Dickinson & Co.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 31, 2013
Initiation Date
June 6, 2013
Classification Date
July 24, 2013
Termination Date
September 3, 2013
Address
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

Description

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.

Reason

Microbiological identification media may exhibit reduced levels of Vancomycin.

Code Info

Lot 3071112 Exp 5/28/13

Distribution

Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Quantity

42 cartons