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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm July 02, 2004
Date Posted August 07, 2004
Recall Status1 Terminated 3 on December 21, 2004
Recall Number Z-1316-04
Recall Event ID 29531
Product Classification Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar - Product Code JSO
Product Sheep Blood, Defibrinated - Catalog Number 211946, Unit 100 ml.
Code Information Lot number: 4155326 and Expiration date: June 29, 2004
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Mr. John Gerlich
Manufacturer Reason
for Recall
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
FDA Determined
Cause 2
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 17 bottles
Distribution 83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.