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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.

Recall number
Z-3028-2011
Recalling firm
Becton Dickinson & Company
Product
BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.
Status
Terminated
Initiated
2011-04-22
Posted
2011-08-16
Terminated
2012-06-06
Reason
BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.
Root cause
Device Design
Action
BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.
Quantity
1,744,000
Distribution
Nationwide (USA) Distribution.
Lot, serial or model codes
Catalog # 367324, Lot #0315173, 0316102, 0323342, 0327441, and 1025938;  Catalog # 367326, Lot #0309244, 0309286, and 0312571;   Catalog #367344, Lot #0334101, 0336557, 0347425, 0354635, and 10131090.
510(k) numbers
not on file
PMA numbers
not on file
Product code
KST
Firm FEI
2243072
Firm city
Franklin Lakes
Firm state
NJ
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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