Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml. 의 리콜

Recall

29531

Class 3

Z-1319-04

2004-07-02

2004-08-07

Terminated

United States

2004-12-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34165

Sheep blood products may be contaminated with a brucella species (b. ovis).

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.