[pending] Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-1822-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
The recalled product
- Product
- Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separa
- Manufacturer
- THERAKOS DEVELOPMENT LIMITED
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model/Catalog Number: CLXUSA
- UDI-DI: 20705030200003
- Lot Numbers: N301
- N339
- N340
- N341
- N342
- N343
- N344
- N345
- N346
- N347
Distribution
Distributed nationwide across the United States.
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