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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.

Recall number
Z-2434-2015
Recalling firm
Becton Dickinson & Company
Product
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
Status
Terminated
Initiated
2015-06-23
Posted
2015-08-20
Terminated
2016-04-06
Reason
Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.
Root cause
Process control
Action
Becton Dickinson notified their affected customers of this recall by sending them an Urgent Product Recall Letter dated June 23, 2015 via UPS 2nd Day.
Quantity
238, 000 (Lot #5133959) and 243,000 (Lot #5133957)
Distribution
Distributed in FL, IL, MA, MI, MO, PA and TN.
Lot, serial or model codes
REF #367986, Lot #'s 5133957 and 5133959
510(k) numbers
["BK050036"]
PMA numbers
not on file
Product code
JKA
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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