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Recall Observatory FDA recall evidence

Device 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.

Z-0606-2014

November 13, 2013

Class II

Product summary

Firm
Instrumentation Industries Inc
Event
Event 66902
Status
Terminated
Classification
Class II
Quantity
220
Official record key
device-enforcement:Z-0606-2014

Official wording

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.

Code information: multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error.