Brand Name: K-Systems Product Name: Multiple/unknown recall
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An…
Why was Brand Name: K-Systems Product Name: Multiple/unknown 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?
Unknown product distributed in India and Australia as lab equipment. Version or Model: Multiple/unknown; Primary DI Number: unknown; Serial Numbers: unknown. NOTE: These devices are one of the five (5) noted affected Part Numbers, so the intended use, etc. will be one of those other devices. As stated above, traceability was not a concern due to the classification of these devices in those regions.
- Product
- Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An…
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 34 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)