Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0777-2007

BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent...

Becton Dickinson & Co / initiated 2007-03-20 / Terminated

Becton Dickinson & Company began a recall of BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides... on . The reason FDA records is "The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0777-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall
The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.
FDA root cause
Other
Action
Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.
Quantity in commerce
147,200 units
Distribution
Nationwide and Canada.
Product codes and lots
Catalog # 368652 Lot Numbers: 5236082; 5236093; 5236095.