Recall Z-0691-2025 ยท PUB Accessory, Assisted Reproduction, Exempt
CooperSurgical, Inc.
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 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.
| Date | Dec 18, 2024 (initiated Nov 15, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | On November 15, 2024 URGENT MEDICAL DEVICE RECALL emails were sent to customers. On November 20, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions that should be taken by the customer/user/distributor in order to prevent risks for patients or users: G85 Mini Incubators with serial numbers listed in the Appendix are impacted and require repair. 1. Inspect your inventory, identify, and discontinue use. 2. Complete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete a |
| Quantity | 43 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.