Z-0606-2014Class II

RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system...

Name: Z-0606-2014 RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system...
Creator: Instrumentation Industries Inc
Published: 2013-11-13
License: https://open.fda.gov/license/

Instrumentation Industries, Incorporated / initiated 2013-11-13 / Terminated / root cause: labeling and UDI

FDA source

Instrumentation Industries Inc began a recall of 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... on 2013-11-13. FDA classified it as Class II and gives the reason as "Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0606-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-13
Posted: 2013-12-29
Terminated: 2014-07-09
Recalling firm: Instrumentation Industries, Incorporated
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.
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: A recall notification letter, dated November 13, 2013, was sent to Users.
Quantity in commerce: 220
Distribution: Nationwide Distribution.
Product codes and lots: multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0606-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0606-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-29

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)