Z-0335-2018Class II

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff...

Name: Z-0335-2018 Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff...
Creator: Hamilton Medical, Inc.
Published: 2017-06-20
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2017-06-20 / Open, Classified / root cause: design

FDA source

Hamilton Medical, Inc. began a recall of Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy... on 2017-06-20. FDA classified it as Class II and gives the reason as "Issue related to the performance of the motor in recalled product. During use, motor may cease to function". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0335-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-06-20
Posted: 2018-01-12
Recalling firm: Hamilton Medical AG
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.
Product code: BSK Cuff, Tracheal Tube, Inflatable
Reason for recall: Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Root cause tag: design
FDA root cause: Component design/selection
Action: Hamilton Medical sent a Recall Notice dated June 20, 2017, notifying them of the device correction. Consignees were informed that a Hamilton Representative would be in contact with them regarding the return of any devices. For further questions, please call (775) 858-3200.
Quantity in commerce: 176 units
Distribution: US Distribution to IL and TX.
Product codes and lots: Serial No. 1000 thru 2090; P/N 951001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0335-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0335-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-12

Product code BSK

K150893Class IIIntelliCuffHamilton Medical AG / cleared 2016-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)