FDA Enforcement
Class II
Terminated
BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
Recall: Z-1334-2013
·
Reported May 22, 2013
Enforcement
- Recall Number
- Z-1334-2013
- Event ID
- 64883
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 22, 2013
- Initiation Date
- March 11, 2013
- Classification Date
- May 16, 2013
- Termination Date
- June 24, 2013
- Address
- BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States
Description
BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
Reason
Microbiological media may be contaminated with bacteria.
Code Info
Model number 221733: lot 2361003 with expiration date 3/14/13
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.
Quantity
521,160 total pieces (all three recalled products)