Reported Dec 25, 2024 · Ongoing
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product…
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 NameT47
- Warming Plate Model/Catalog NumberK23055
- 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
- ComponentNo
- Lot codes and dates
- Version or ModelK23055
- Primary DI Number00888937025064
- Serial Numbers
180 of 180 codes
2223KH012223KH022223KH032223KH042223KH052223KH062223KH072223KH082223KH092223KH102235KH212235KH222235KH232235KH242235KH252235KH262235KH272235KH282235KH292235KH302237KH012237KH022237KH032237KH042237KH052237KH062237KH072237KH082237KH092237KH102250KH112250KH122250KH132250KH142250KH152250KH162250KH172250KH182250KH192250KH202303KH412303KH422303KH432303KH442303KH452303KH462303KH472303KH482303KH492303KH502309KH312309KH322309KH332309KH342309KH352309KH362309KH372309KH382309KH392309KH40
- Amount recalled
- 35 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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