Recall Z-1325-04 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Becton Dickinson & Co.
BBL Brain Heart Infusion Agar CC w/Sheep Blood - Catalog Number 296178.
| Date | Aug 7, 2004 (initiated Jul 2, 2004) |
| Status | Terminated |
| Reason | Sheep Blood products may be contaminated with a Brucella species (B. ovis). |
| Root cause | Other |
| Action | Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail. Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04). Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return. Response forms will be reconciled. Distribution of the affected lots |
| Quantity | 480 each |
| Distribution | 83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.