FDAClass IIJune 3, 2015

KimVent Turbo-Cleaning Closed Suction System for Adults recall

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

Why was KimVent Turbo-Cleaning Closed Suction System for Adults 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303

Product
KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults…
Recalling firm
Halyard Health, Inc
Quantity
11 cases each containing 20 individual endotracheal tubes
Distribution
Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls