Surgical Device KliniTray Recalled Due to Microbial Contamination Risk
The KliniTray tissue resection margin examination board is being recalled due to potential microbial contamination. Healthcare facilities should discontinue use and contact the manufacturer for further instructions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device with potential for high-risk microbial contamination, a risk-of-harm hazard applicable to surgical equipment. However, no illnesses or injuries have been reported, and the contamination is described as potential rather than confirmed, limiting the score to 3 per the rubric.
Plain-English summary
The KliniTray (Model 2001105-F) is a tissue resection margin examination board used to monitor and visualize alignment during surgical procedures, ensuring precise tissue positioning. The device is manufactured by Klinika Medical Gmb.
The device is being recalled due to potential for microbial contamination. The recall involves 620 units of lot number 25.019.01 (UDI-DI: 4053185001177). The affected units have been distributed in the United States, including Massachusetts.
Healthcare facilities and surgical centers that have this device should discontinue use of affected units and contact the manufacturer, Klinika Medical Gmb, for instructions regarding return or corrective action. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and posi
- Manufacturer
- Klinika Mdical Gmb
- Hazard
- microbial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
Distribution
Distributed nationwide across the United States.
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