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Therakos, Inc. Recall 88852

Description: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Therakos, Inc. Recall 88852 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0212-2022
Event ID88852
Event DescriptionTHERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Product TypeDevices
QuantityFive (5) Cases -3 Kits/Case= 15 Kits
Recall ReasonProduct was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Device Classification20211117
Device Code InfoLOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Center Classification Date20211105
Recall Initiation Date20211004
Recalling FirmTherakos, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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