FDA recall Z-0809-2021

Product

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.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-16

Report date

2021-01-20

Termination date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

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