Class 2 Device Recall KSystems

• Date Initiated by Firm: November 15, 2024
• Date Posted: December 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0688-2025
• Recall Event ID: 95741
• Product Classification: Accessory, assisted reproduction, exempt - Product Code PUB
• Product: 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
• Code Information: 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.
• FEI Number: 1216677
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Karen Gienau; 001-203-4054510
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. 3. Contact your local Service Representative to arrange a repair at no cost to you. T45, T47, R65, and G73 with serial numbers listed in the Appendix may be impacted and require inspection to determine the need for 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 and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. 3. Contact your local Service Representative to arrange an inspection of the affected product. If your product is affected, the product will be repaired at no cost to you. 6. Actions planned by CooperSurgical to correct the problem CooperSurgical is currently investigating this issue and determined a field action notice to customers is needed to inspect and repair all affected products in the field. CooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harm can be avoided. If you need any further
• Quantity in Commerce: 37 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, 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.