Therakos, Inc. Recall 88852
Description: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Therakos, Inc. Recall 88852 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0212-2022 |
| Event ID | 88852 |
| Event Description | THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA |
| Product Type | Devices |
| Distribution | IL |
| Quantity | Five (5) Cases -3 Kits/Case= 15 Kits |
| Recall Reason | Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury. |
| Device Classification | 20211117 |
| Device Code Info | LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201 |
| Center Classification Date | 20211105 |
| Recall Initiation Date | 20211004 |
| Recalling Firm | Therakos, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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