Reported Dec 25, 2024 · Ongoing
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description:…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- Brand NameK-Systems
- Product NameR65
- Trolley Model/Catalog NumberK24012
- 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
- Version or ModelK24012
- Primary DI Number00888937025026
- Serial Numbers
85 of 85 codes
2234KH012234KH022234KH032234KH042234KH052234KH062234KH072234KH082234KH092234KH102235KH412235KH422235KH432235KH442235KH452235KH462235KH472235KH482235KH492235KH502235KH512235KH522235KH532235KH542235KH552235KH562235KH572235KH582235KH592235KH602243KH012243KH022243KH032243KH042243KH052243KH062243KH072243KH082243KH092243KH102243KH112243KH122243KH132243KH142243KH152243KH162243KH172243KH182243KH192243KH202307KH012307KH022307KH032307KH042307KH052307KH062307KH072307KH082307KH092307KH10
- Amount recalled
- 43 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
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.
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