ClearanceBrief
Recall Z-0606-2014 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

Instrumentation Industries Inc

RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.

DateDec 29, 2013 (initiated Nov 13, 2013)
StatusTerminated
ReasonSome packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.
Root causeLabeling Change Control
ActionA recall notification letter, dated November 13, 2013, was sent to Users.
Quantity220
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.