medical MODERATE Updated 2024-12-25

CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Mode

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Recalled Product

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 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

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Hazard / Issue

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.

Issued by

FDA

Affected States: NC, NJ, TX, VA, IL, NY, CA, PA, DE, ID, IN, MA, MT, SD

Lot/Code Info: Version or Model: K23055; Primary DI Number: 00888937025064; Serial Numbers: 2223KH01 , 2223KH02 , 2223KH03 , 2223KH04 , 2223KH05 , 2223KH06 , 2223KH07 , 2223KH08 , 2223KH09 , 2223KH10 , 2235KH21 , 2235KH22 , 2235KH23 , 2235KH24 , 2235KH25 , 2235KH26 , 2235KH27 , 2235KH28 , 2235KH29 , 2235KH30 , 2237KH01 , 2237KH02 , 2237KH03 , 2237KH04 , 2237KH05 , 2237KH06 , 2237KH07 , 2237KH08 , 2237KH09 , 2237KH10 , 2250KH11 , 2250KH12 , 2250KH13 , 2250KH14 , 2250KH15 , 2250KH16 , 2250KH17 , 2250KH18 , 2250KH19 , 2250KH20 , 2303KH41 , 2303KH42 , 2303KH43 , 2303KH44 , 2303KH45 , 2303KH46 , 2303KH47 , 2303KH48 , 2303KH49 , 2303KH50 , 2309KH31 , 2309KH32 , 2309KH33 , 2309KH34 , 2309KH35 , 2309KH36 , 2309KH37 , 2309KH38 , 2309KH39 , 2309KH40 , 2311KH16 , 2311KH17 , 2311KH18 , 2311KH19 , 2311KH20 , 2311KH21 , 2311KH22 , 2311KH23 , 2311KH24 , 2311KH25 , 2320KH41 , 2320KH42 , 2320KH43 , 2320KH44 , 2320KH45 , 2320KH46 , 2320KH47 , 2320KH48 , 2320KH49 , 2320KH50 , 2324KH33 , 2324KH34 , 2324KH35 , 2324KH36 , 2324KH37 , 2324KH38 , 2324KH39 , 2324KH40 , 2324KH41 , 2324KH42 , 2327KH20 , 2327KH21 , 2327KH22 , 2327KH23 , 2327KH24 , 2327KH25 , 2327KH26 , 2327KH27 , 2327KH28 , 2327KH29 , 2333KH01, 2333KH02, 2333KH03, 2333KH04, 2333KH05, 2333KH06, 2333KH07, 2333KH08, 2333KH09, 2333KH10, 2333KH21, 2333KH22, 2333KH23, 2333KH24, 2333KH25, 2333KH26, 2333KH27, 2333KH28, 2333KH29, 2333KH30, 2333KH31, 2333KH32, 2333KH33, 2333KH34, 2333KH35, 2335KH51, 2335KH52, 2335KH53, 2335KH54, 2335KH55, 2335KH56, 2335KH57, 2335KH58, 2335KH59, 2335KH60, 2335KH61, 2335KH62, 2335KH63, 2335KH64, 2335KH65, 2335KH66, 2335KH67, 2335KH68, 2335KH69, 2335KH70, 2335KH71, 2335KH72, 2335KH73, 2335KH74, 2335KH75, 2335KH76, 2335KH77, 2335KH78, 2335KH79, 2335KH80, 2335KH81, 2335KH82, 2335KH83, 2335KH84, 2335KH85, 2335KH86, 2335KH87, 2335KH88, 2335KH89, 2335KH90, 2345KH11, 2345KH12, 2345KH13, 2345KH14, 2345KH15, 2345KH16, 2345KH17, 2345KH18, 2345KH19, 2345KH20, 2345KH21, 2345KH22, 2345KH23, 2345KH24, 2345KH25,

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Mode

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