ClearanceBrief
Recall Z-1561-05 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive

Becton Dickinson Medical Systems

BD DTX Plus, 12'' single-line neonatal pressure monitoring kit.

DateSep 21, 2005 (initiated Jul 1, 2005)
StatusTerminated
ReasonActuating tab may detach from the stopcock body, allowing fluid leak.
Root causeOther
ActionConsignees were notified by phone and fax on 07/01/2004.
Quantity1060 units
DistributionNationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K935782DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
Ohmeda Medical, Aug 1, 1994