Z-0528-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 12, 2018
- Initiation Date
- October 22, 2018
- Termination Date
- April 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,300 plates
Product Description
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Reason for Recall
a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
Distribution Pattern
US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV
Code Information
UDI - (01)10382902212611(17)181130 (10)8221508 Lot No.: 8221508 Expiration Date: 2018-11-30