Hamilton Medical Recalls Intellicuff Standalone Devices Due to Motor Failure
Hamilton Medical is recalling 176 Intellicuff Standalone devices because the motor may cease to function during use, potentially affecting endotracheal tube cuff pressure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a critical life-support device where motor failure could lead to harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Hamilton Medical, Inc. is recalling 176 units of the Intellicuff Standalone (PN 951001). This medical device is used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation for adults, pediatrics, and neonates.
The recall is due to a performance issue with the motor in the recalled product. During use, the motor may cease to function. The affected units have serial numbers 1000 through 2090 and part number 951001.
The devices were distributed in the United States to Illinois and Texas. Healthcare facilities and users should stop using the affected devices and contact Hamilton Medical for instructions on replacement or repair.
The recalled product
- Product
- Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
- Manufacturer
- Hamilton Medical, Inc.
- Affected units
- 176
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 (2)
- Serial No. 1000 thru 2090
- P/N 951001
Distribution
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