Medical device recalls Moderate risk

Intersurgical Inc recalls Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

Recall date
August 7, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0784-2020
FDA classification
Class II
Brand / firm
Intersurgical Inc
Sold / distributed
US Nationwide

Why it was recalled

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

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

What was recalled

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

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