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/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir Sparks MD 21152-9212
|
For Additional Information Contact | Mr. John Gerlich 410-316-4464 |
Manufacturer Reason for Recall | Sheep Blood products may be contaminated with a Brucella species (B. ovis). |
FDA Determined Cause 2 | 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 | 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.
|