510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2710-2016Class II

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...

Becton Dickinson & Co / initiated 2016-08-08 / Terminated

Becton Dickinson & Company began a recall of 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 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2710-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
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.
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall
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.
FDA root cause
Under Investigation by firm
Action
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.
Quantity in commerce
1,788,150 units
Distribution
US and International
Product codes and lots
Lot number: 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634 and 6006650.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2710-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2710-2016Class IITerminatedVoluntary: Firm initiated