Z-0976-2015 Class II Terminated
FDA device recall Z-0976-2015 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: 775 cases.
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
- 775 cases
Product Description
Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.
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 # 221263 with Lot #4099228
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0976-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026