RTC 25-C Inline Aerosol Tee Adapter Recalled for Incomplete Instructions
Instrumentation Industries Inc. is recalling 220 units of the RTC 25-C Inline Aerosol Tee Adapter because some packages were shipped with incomplete installation and usage directions due to a printing error.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a documentation error (incomplete instructions) rather than a direct physical defect or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Instrumentation Industries Inc. is recalling 220 units of the RTC 25-C Inline Aerosol Tee Adapter. This device is intended to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit. The recall was initiated because some packages were shipped to customers with incomplete Installation and Usage Directions due to a printing error.
The affected units were distributed nationwide. The recall covers multiple lots shipped between October 7, 2013, and November 6, 2013. The specific lot numbers involved are P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.
Consumers and healthcare facilities should check their inventory for these specific lot numbers. If the product is found, they should stop using it and contact Instrumentation Industries Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- 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.
- Manufacturer
- Instrumentation Industries Inc
- Affected units
- 220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- multiple lots shipped between 10/7/13 and 11/6/13: P1002913
- P1004413
- P1005713
- P1007713
- P1009813
- P1014213
- P1014813
- and P1102013.
Distribution
Distributed nationwide across the United States.
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