Recall Z-0809-2021 ยท MQG Accessory, Assisted Reproduction
Cook Medical Llc
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
| Date | Dec 16, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 12/16/20 was sent to customers. Action to be Taken: As a precautionary measure, we recommend that users perform two in-house checks prior to using a new flask to improve detection of the manufacturing defect. 1. Visual Inspection Check the flask assembly: when the stopper is placed on the flask, the tab on the silicone stopper should engage with the indent in the flask. Flasks that have the defect may not allow the stopper to be fully pushed into the indent of flasks, as shown in Figure 1. 2. Leak Test Check for leaks: Flasks that |
| Quantity | 56250 |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983642 | COOK MINI-INCUBATOR Cook Ob/Gyn, Feb 1, 1999 |