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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Co.: Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.

Recall number
Z-1319-04
Recalling firm
Becton Dickinson & Co.
Product
Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.
Status
Terminated
Initiated
2004-07-02
Posted
2004-08-07
Terminated
2004-12-21
Reason
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
Root cause
Other
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.
Quantity
1 bottle
Distribution
83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.
Lot, serial or model codes
Lot number: 4155332 and Expiration date: June 29, 2004
510(k) numbers
not on file
PMA numbers
not on file
Product code
JSO
Firm FEI
1119779
Firm city
Sparks
Firm state
MD
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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