Recall Z-0528-2019 ยท JSG Culture Media, Non-Selective And Non-Differential
Becton Dickinson & Co.
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
| Date | Nov 30, 2018 (initiated Oct 22, 2018) |
| Status | Terminated |
| Reason | a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms. |
| Root cause | Mixed-up of materials/components |
| Action | Distributors were notified via email on October 22, 2018, requesting their customer distribution list. Customer letters were sent via UPS beginning on October 29, 2018. **Distributors are Advised to do the following: 1.Discard any remaining inventory of the above referenced product. 2.Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 3.Within three days, provide an Excel file or a list with |
| Quantity | 54,300 plates |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.