Recall Z-1800-2013— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-06-06, terminated 2013-09-03. It names one FDA 510(k) clearance: K803022. 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.. Reason: Microbiological identification media may exhibit reduced levels of Vancomycin..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-06
- Terminated
- 2013-09-03
- Firm location
- Sparks, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Microbiological identification media may exhibit reduced levels of Vancomycin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.