Medical device recalls Moderate risk

Cook Medical Llc recalls Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

Recall date
December 16, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0809-2021
FDA classification
Class II
Brand / firm
Cook Medical Llc
Sold / distributed
US Nationwide

Why it was recalled

A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.

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

What was recalled

Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

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