Z-0196-2018 Class II Terminated
FDA device recall Z-0196-2018 was initiated by Becton Dickinson & Co. on May 22, 2017 and is designated Class II. Reason for recall: Listeria monocytogenes contamination of non-sterile plated media The recall status is terminated (terminated February 26, 2018). Affected quantity: 250, 300 plates.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- February 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250, 300 plates
Product Description
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.
Reason for Recall
Listeria monocytogenes contamination of non-sterile plated media
Distribution Pattern
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FA, HI, IA, IS, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT & WA; International - Canada, Guam and Japan
Code Information
Lot Number: 7032978 - Exp Date May 24, 2017 7048902 - Exp Date June 9, 2017