—#138431

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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: BK050036
Affected lot / code info: REF #367986, Lot #'s 5133957 and 5133959

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distributed in FL, IL, MA, MI, MO, PA and TN.

Timeline

Recall initiated: 2015-06-23
Posted by FDA: 2015-08-20
Terminated: 2016-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138431. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.