CooperSurgical, Inc. Recall 95741
Description: Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
CooperSurgical, Inc. Recall 95741 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0688-2025 |
| Event ID | 95741 |
| Event Description | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No |
| Product Type | Devices |
| Distribution | States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines. Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA |
| Quantity | 37 units |
| Recall Reason | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. |
| Device Classification | 20241225 |
| Device Code Info | Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04 , 2244KH05 , 2244KH06 , 2244KH07 , 2244KH08 , 2244KH09 , 2244KH10 , 2313KH01 , 2313KH02 , 2313KH03 , 2313KH04 , 2313KH05 , 2313KH06 , 2313KH07 , 2313KH08 , 2313KH09 , 2313KH10 , 2320KH21 , 2320KH22 , 2320KH23 , 2320KH24 , 2320KH25 , 2320KH26 , 2320KH27 , 2320KH28 , 2320KH29 , 2320KH30 , 2321KH16 , 2321KH17 , 2321KH18 , 2321KH19 , 2321KH20, |
| Center Classification Date | 20241218 |
| Recall Initiation Date | 20241115 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Telephone |
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