Drug recall
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
FDA recall event 86965 · Class II · Cook Medical Llc
Key facts
| Event ID | 86965 |
|---|---|
| Recall numbers | Z-0809-2021 |
| Recalling firm | Cook Medical Llc |
| Product type | Devices |
| Products | Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 16, 2020 |
| Report date | Jan 20, 2021 |
| Termination date | Nov 8, 2023 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 3007965706 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: