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BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x… recallZ-2434-2015 · Becton Dickinson & Company · initiated Jun 23, 2015

Class III Terminated All recalls posted in August 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2434-2015
Recall class
Class III
Status
Terminated
Initiated by the company
Jun 23, 2015
Posted by the FDA
Aug 20, 2015
Recalling firm
Becton Dickinson & Company
Quantity
238, 000 (Lot #5133959) and 243,000 (Lot #5133957)
Product code
JKA
FDA submissions
BK050036
Distribution
Distributed in FL, IL, MA, MI, MO, PA and TN.

Product description

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.

Code information (models, lots, serial numbers)

REF #367986, Lot #'s 5133957 and 5133959

Other devices under the same FDA submission

31 devices cleared under BK050036 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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