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

Recall date

April 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1678-2015

FDA classification

Class II

Brand / firm

Halyard Health, Inc

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).