Intersurgical Inc recalls Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

Recall date

April 25, 2018

Source

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

Recall number

Z-2302-2018

FDA classification

Class II

Brand / firm

Intersurgical Inc

Sold / distributed

Distributors in IL, NJ, NV, TX, UT.

Why it was recalled

When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.

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

What was recalled

Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000