Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A…

Is this the product you have?

• Brand NameK-Systems
• Product NameMultiple/unknown
• Model/Catalog NumberMultiple/unknown
• Software VersionN/A
• Product DescriptionAn 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
• ComponentN/A

Lot codes and dates

• Unknown product distributed in India and Australia as lab equipment
• Version or ModelMultiple/unknown
• Primary DI Numberunknown
• Serial Numbersunknown
• NOTEThese 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

Amount recalled

34 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

• Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/
• Brand Name: K-Systems Product Name: G85 Mini Incubator Model/
• Brand Name: K-Systems Product Name: T47 Warming Plate Model/
• Brand Name: K-Systems Product Name: T47 Warming Plate Model/
• Brand Name: K-Systems Product Name: R65 Trolley Model/

Where it was sold

• NC
• NJ
• TX
• VA
• IL
• NY
• CA
• PA
• DE
• ID
• IN
• MA
• MT
• SD

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.