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.
FDA Recall Z-0335-2018 · Posted None
Advertisement
Recalling FirmHamilton Medical, Inc.
Recall StatusOpen, Classified
Product CodeBSK
Date Initiated2017-06-20
Product Quantity176 units
Reason for Recall
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
US Distribution to IL and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement