FDAClass IIMay 21, 2025

KliniTray Platte Faxitron recall: Contamination

KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is…

Why was KliniTray Platte Faxitron recalled?

Potential for microbial contamination.

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?

Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01

Product
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is…
Recalling firm
Klinika Mdical Gmb
Quantity
160 units
Distribution
US Nationwide distribution in the state of Massachusetts.
Recall date
May 21, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls