Reported Jan 24, 2018 · Ongoing
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure…
Hamilton Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hamilton Medical, Inc. · 4990 Energy Way · Reno, NV · 89502-4123
Is this the product you have?
- 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.
- Lot codes and dates
Serial No. 1000 thru 2090P/N 951001
- Amount recalled
- 176 units
Where it was sold
Why it was recalled
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
This product could cause temporary or reversible health problems — stop using it.
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