Brand Name: K-Systems Product Name: R65 Trolley recall
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device…
Why was Brand Name: K-Systems Product Name: R65 Trolley recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version or Model: K24012; Primary DI Number: 00888937025026; Serial Numbers: 2234KH01, 2234KH02, 2234KH03, 2234KH04, 2234KH05, 2234KH06, 2234KH07, 2234KH08, 2234KH09, 2234KH10, 2235KH41, 2235KH42, 2235KH43, 2235KH44, 2235KH45, 2235KH46, 2235KH47, 2235KH48, 2235KH49, 2235KH50, 2235KH51, 2235KH52, 2235KH53, 2235KH54, 2235KH55, 2235KH56, 2235KH57, 2235KH58, 2235KH59, 2235KH60, 2243KH01, 2243KH02, 2243KH03, 2243KH04, 2243KH05, 2243KH06, 2243KH07, 2243KH08, 2243KH09, 2243KH10, 2243KH11, 2243KH12, 2243KH13, 2243KH14, 2243KH15, 2243KH16, 2243KH17, 2243KH18, 2243KH19, 2243KH20, 2307KH01, 2307KH02, 2307KH03, 2307KH04, 2307KH05, 2307KH06, 2307KH07, 2307KH08, 2307KH09, 2307KH10, 2320KH11, 2320KH12, 2320KH13, 2320KH14, 2320KH15, 2320KH16, 2320KH17, 2320KH18, 2320KH19, 2320KH20, 2337KH11, 2337KH12, 2337KH13, 2337KH14, 2337KH15, 2337KH16, 2337KH17, 2337KH18, 2337KH19, 2337KH20, 2340KH01, 2340KH02, 2340KH03, 2340KH04, 2340KH05,
- Product
- Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device…
- Recalling firm
- CooperSurgical, Inc.
- 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, 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
- Recall date
- December 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)