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U.S. Department of Health and Human Services

Class 2 Device Recall KimVent

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  Class 2 Device Recall KimVent see related information
Date Initiated by Firm April 14, 2015
Date Posted May 26, 2015
Recall Status1 Terminated 3 on July 07, 2015
Recall Number Z-1678-2015
Recall Event ID 71110
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
Code Information M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, PhD
470-448-5681
Manufacturer Reason
for Recall		 The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit.
FDA Determined
Cause 2		 Device Design
Action Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.
Quantity in Commerce 11 cases each containing 20 individual endotracheal tubes
Distribution Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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