Z-0974-2015 Class II Terminated
FDA device recall Z-0974-2015 was initiated by Becton Dickinson & Co. on Jun 6, 2014 and is designated Class II. Reason for recall: A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the… The recall status is terminated (terminated Aug 12, 2016). Affected quantity: 7,617 cases (100 plates/case).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 21, 2015
- Initiation Date
- Jun 6, 2014
- Termination Date
- Aug 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,617 cases (100 plates/case)
Product Description
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
Reason for Recall
A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.
Distribution Pattern
Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
Code Information
Catalogue # 221291 with Lot #4050354, 4086399, 4099206 and 4143653; Catalogue #221261 with Lot # 4022158 4086443 4092199
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0974-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026