Laerdal Compact Suction Unit recalled over suffocation hazard

Recall date

December 18, 2020

Source

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

Official notice title

Laerdal Medical (Suzhou) Co., Ltd. recalls Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage:…

Recall number

Z-0868-2021

FDA classification

Class II

Brand / firm

Laerdal Medical (Suzhou) Co., Ltd.

Sold / distributed

Worldwide distribution - US Nationwide distribution.

Why it was recalled

Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.

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

What was recalled

Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.