PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 20, 2021 Initiated: December 16, 2020 #Z-0809-2021

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Cook Medical Llc
Units Affected
56250
Distribution
US Nationwide
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707. Recalled by Cook Medical Llc. Units affected: 56250.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0809-2021.