Events

Recall of Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29531
  • Event Risk Class
    Class 3
  • Event Number
    Z-1317-04
  • Event Initiated Date
    2004-07-02
  • Event Date Posted
    2004-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34163
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar - Product Code JSO
  • Reason
    Sheep blood products may be contaminated with a brucella species (b. ovis).
  • 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.

Device

Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.
  • Model / Serial
    Lot number: 4155341 and Expiration date: June 29, 2004
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.
  • Product Description
    Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA