—#148749

Product

BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K030573
Affected lot / code info: Lot number: 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634 and 6006650.

Why it was recalled

Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD notified their customers via e-mail and sent an "Urgent Product Recall Letter" and a Recall Response Form dated August 8, 2016 via UPS.

Recalling firm

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

Distribution

Distribution pattern: US and International

Timeline

Recall initiated: 2016-08-08
Terminated: 2017-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.