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Device Recall Therakos CellEx Photopheresis System
Model / Serial
CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
Product Classification
Gastroenterology-Urology Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution, and Canada and Germany
Product Description
Therakos CellEx Photopheresis System; || Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
Manufacturer
Therakos Inc
1 Event
Recall of Device Recall Therakos CellEx Photopheresis System
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Manufacturer
Therakos Inc
Manufacturer Address
Therakos Inc, 1001 Us Highway 202, Raritan NJ 08869
Manufacturer Parent Company (2017)
Mallinckrodt Plc
Source
USFDA
Language
English
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