Recall Z-0606-2014— Instrumentation Industries Inc
Class II · Terminated
Class II FDA medical device recall by Instrumentation Industries Inc, initiated 2013-11-13, terminated 2014-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error..
- Recalling firm
- Instrumentation Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-13
- Terminated
- 2014-07-09
- Firm location
- Bethel Park, PA, United States
Product description
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.
Reason for recall
Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.