Recall Z-1800-2013
Becton Dickinson & Co. · initiated June 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.
Codes / lots: Lot 3080083 Exp 6/4/13 Lot 3073075 Exp 5/29/13
Reason for recall
Microbiological identification media may exhibit reduced levels of Vancomycin.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1800-2013
- Initiated
- June 6, 2013
- Posted by FDA
- July 24, 2013
- Terminated
- September 3, 2013
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Quantity
- 45 cartons
- Distribution
- Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1798-2013 Class II | BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |
| Z-1799-2013 Class II | BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |
| Z-1801-2013 Class II | BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |
| Z-1802-2013 Class II | BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |
| Z-1803-2013 Class II | BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |
| Z-1804-2013 Class II | BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |
| Z-1805-2013 Class II | BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged…Microbiological identification media may exhibit reduced levels of Vancomycin. | 06/06/2013Terminated |