FDAClass IIJanuary 24, 2018

Intellicuff Standalone recall

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or…

Why was Intellicuff Standalone recalled?

Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial No. 1000 thru 2090; P/N 951001

Product
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or…
Recalling firm
Hamilton Medical, Inc.
Quantity
176 units
Distribution
US Distribution to IL and TX.
Recall date
January 24, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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