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Terminated

BBL Columbia C.N.A. Agar w/5% Sheep Blood - Catalog Number 297831.

FDA Recall Z-1326-04 · Posted 2004-08-07

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJSO
Date Initiated2004-07-02
Date Terminated2004-12-21
Product Quantity150 each

Reason for Recall

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Firm 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.

Root Cause

Other

Distribution Pattern

83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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