Sheep Blood, Defibrinated - Catalog Number 211945, Unit 15 ml.

FDA device recall Z-1320-04 · posted 2004-08-07 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JSO

Quantity affected

9 vials

Distribution

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

Date initiated

2004-07-02

Date posted

2004-08-07

Date terminated

2004-12-21

Location

Sparks, MD