Recall Z-0335-2018 ยท BSK Cuff, Tracheal Tube, Inflatable
Hamilton Medical, Inc.
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.
| Date | Jun 20, 2017 |
| Status | Open, Classified |
| Reason | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
| 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 | 176 units |
| Distribution | US Distribution to IL and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150893 | IntelliCuff Hamilton Medical AG, Jan 29, 2016 |