# FDA recall Z-0809-2021

> **Cook Medical Llc** · Class II · device recall initiated 2020-12-16.

## 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

- **Recall number:** Z-0809-2021
- **Recalling firm:** Cook Medical Llc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0809-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0809-2021. Source: US FDA. Licensed CC0.

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