Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Sheep Blood, Defibrinated - Catalog Number 211946, Unit 100 ml.

FDA Recall Z-1316-04 · Posted 2004-08-07

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJSO
Date Initiated2004-07-02
Date Terminated2004-12-21
Product Quantity17 bottles

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.

↑