Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1565-05

BD DTX Plus, Custom dual-line pressure monitoring kit

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2005-07-01 / Terminated

Becton Dickinson Medical Systems began a recall of BD DTX Plus, Custom dual-line pressure monitoring kit on . The reason FDA records is "Actuating tab may detach from the stopcock body, allowing fluid leak". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1565-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson Infusion Therapy Systems Inc.
Product
BD DTX Plus, Custom dual-line pressure monitoring kit.
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall
Actuating tab may detach from the stopcock body, allowing fluid leak.
FDA root cause
Other
Action
Consignees were notified by phone and fax on 07/01/2004.
Quantity in commerce
405 units
Distribution
Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
Product codes and lots
Part number 687341, Lot Numbers: 410177, 411063, 411540.