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Class 2 Device Recall KimVent |
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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
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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
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For Additional Information Contact |
Thomas Kozma, PhD 470-448-5681
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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.
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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
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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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