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Terminated

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.

FDA Recall Z-0606-2014 · Posted 2013-12-29

Recalling FirmInstrumentation Industries Inc
Recall StatusTerminated
Product CodeCAI
Date Initiated2013-11-13
Date Terminated2014-07-09
Product Quantity220

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.

Firm Action

A recall notification letter, dated November 13, 2013, was sent to Users.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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