Recalls / —

—#34172

Product

BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.

FDA product code

JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Device class

Class 2

Medical specialty

Microbiology

Affected lot / code info

Lot number: 4153582 and Expiration date: September 09, 2004

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson & Co.

Address

7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern

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

Timeline

Recall initiated

2004-07-02

Posted by FDA

2004-08-07

Terminated

2004-12-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.