FDA Medical Device Recalls (openFDA)
Instrumentation Industries Inc: 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.
- Recall number
- Z-0606-2014
- Recalling firm
- Instrumentation Industries Inc
- 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.
- Status
- Terminated
- Initiated
- 2013-11-13
- Posted
- 2013-12-29
- Terminated
- 2014-07-09
- 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.
- Root cause
- Labeling Change Control
- Action
- A recall notification letter, dated November 13, 2013, was sent to Users.
- Quantity
- 220
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAI
- Firm FEI
- 2518436
- Firm city
- Bethel Park
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28