Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Disposable Humidification Flask K-MINC-CTS-S QCR-106 [Order number: G32707, All lots are affected], which is used in conjunction with the Mini Incubator, K-MINC-1000 for cell culture.
According to the manufacturer, a small percentage of this product 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. Inadequate gas flow to the incubation chambers may result in degeneration or loss of embryo.
Affected users should note that devices are not needed to be returned. Those who received the flasks should perform two in-house checks prior to using a new flask to improve detection of the manufacturing defect.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your local supplier for necessary action.
Posted on 17 December 2020