Z-0528-2019 Class II Terminated
FDA device recall Z-0528-2019 was initiated by Becton Dickinson & Co. on Oct 22, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 3, 2020). Affected quantity: 54,300 plates.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 22, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0528-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026