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U.S. Department of Health and Human Services

Class 2 Device Recall Continuous Ventilator

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 Class 2 Device Recall Continuous Ventilatorsee related information
Date Initiated by FirmJune 20, 2017
Create DateJanuary 12, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0335-2018
Recall Event ID 77617
510(K)NumberK150893 
Product Classification Cuff, tracheal tube, inflatable - Product Code BSK
ProductIntellicuff 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.
Code Information Serial No. 1000 thru 2090; P/N 951001
Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4990 Energy Way
Reno NV 89502-4123
For Additional Information ContactBret Everett
775-858-3200
Manufacturer Reason
for Recall		Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
FDA Determined
Cause 2		Component design/selection
ActionHamilton 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 Commerce176 units
DistributionUS Distribution to IL and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSK
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