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.
This recall has been terminated (originally issued December 29, 2013).
- Company
- Instrumentation Industries Inc
- Recall Initiated
- November 13, 2013
- Posted
- December 29, 2013
- Terminated
- July 9, 2014
- Recall Number
- Z-0606-2014
- Quantity
- 220
- Firm Location
- Bethel Park, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.
Root Cause
Labeling Change Control
Action Taken
A recall notification letter, dated November 13, 2013, was sent to Users.
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