Cook Medical Recalls Disposable Humidification Flasks Due to Stopper Defect
Cook Medical is recalling 56,250 Disposable Humidification Flasks because a manufacturing defect may cause silicone stoppers to dislodge or gas to leak, impeding gas flow to incubation chambers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves a functional defect in a medical device that impedes gas flow, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cook Medical LLC is recalling 56,250 units of the Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707. The recall is due to a manufacturing defect that may cause the silicone stoppers to dislodge or gas to leak from the flasks. This defect can impede gas flow to the incubation chambers of the Mini Incubator.
The affected products were distributed nationwide in the United States. The recall covers specific lot numbers listed in the official FDA record Z-0809-2021. No illnesses or injuries have been reported in the source text.
Healthcare facilities and consumers should stop using the affected flasks and contact Cook Medical for further instructions or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
- Manufacturer
- Cook Medical Llc
- Category
- Medical Device — Neonatal Care
- Affected units
- 56,250
Distribution
Distributed nationwide across the United States.
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