Reported Jun 3, 2015 · Terminated

KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning…

Halyard Health, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Halyard Health, Inc · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
227105KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece ( )
2271603KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE ( )
227135KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece ( ).
Lot codes and dates
    • M5019T311
    • M4335T317
    • M5034T317
    • M5040T311 & M5005T303
Amount recalled
11 cases each containing 20 individual endotracheal tubes

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 7, 2015 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.