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Recall Observatory FDA recall evidence

Device 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).

Z-1678-2015

April 14, 2015

Class II

Product summary

Firm
Halyard Health, Inc
Event
Event 71110
Status
Terminated
Classification
Class II
Quantity
11 cases each containing 20 individual endotracheal tubes
Official record key
device-enforcement:Z-1678-2015

Official wording

Reason: 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.

Code information: M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303

Distribution pattern: Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.