Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1319-04

Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml

Becton Dickinson & Co / initiated 2004-07-02 / Terminated

Becton Dickinson & Co. began a recall of Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml on . The reason FDA records is "Sheep Blood products may be contaminated with a Brucella species (B. ovis)". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1319-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.
Product code
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
FDA 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 ceased on 7/1/04. Customers are asked to discard their inventory.
Quantity in commerce
1 bottle
Distribution
83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.
Product codes and lots
Lot number: 4155332 and Expiration date: June 29, 2004