Recall archive / FDA device enforcement
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA — FDA record Z-0212-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 4, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
- 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.
- Classification
- Class II
- Recalling firm
- Therakos, Inc.
- Quantity
- Five (5) Cases -3 Kits/Case= 15 Kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0212-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
IL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 17, 2021
- Recall initiation date
- Oct 4, 2021
- Center classification date
- Nov 5, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.