Recall Z-0809-2021— Cook Medical Llc
Class II · Terminated
Class II FDA medical device recall by Cook Medical Llc, initiated 2020-12-16, terminated 2023-11-08. It names one FDA 510(k) clearance: K983642. Product: Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707. Reason: 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..
- Recalling firm
- Cook Medical Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-16
- Terminated
- 2023-11-08
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.