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).
FDA Recall Z-1678-2015 · Posted 2015-05-26
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Recalling FirmHalyard Health, Inc
Recall StatusTerminated
Product CodeBSY
Date Initiated2015-04-14
Date Terminated2015-07-07
Product Quantity11 cases each containing 20 individual endotracheal tubes
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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