FDA-Device2021-01-20Class II

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

Cook Medical Llc
Hazard

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.

Sold states
US Nationwide
Affected count
56250
Manufactured in
1025 W Acuff Rd, N/A, Bloomington, IN, United States
Products
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2021

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