ClearanceBrief
Recall Z-2710-2016 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Becton Dickinson & Company

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.

DateAug 8, 2016
StatusTerminated
ReasonBecton 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 causeUnder Investigation by firm
ActionBD notified their customers via e-mail and sent an "Urgent Product Recall Letter" and a Recall Response Form dated August 8, 2016 via UPS.
Quantity1,788,150 units
DistributionUS and International
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
Bd Vacutainer Systems Preanalyical Solutions, May 8, 2003