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