Brand Name: Cellex Photopheresis System Product Name recall
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product…
Why was Brand Name: Cellex Photopheresis System Product Name recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: CLXUSA; UDI-DI: 20705030200003; Lot Numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347; P302, P303, P304, P305, P306, P307, P308, P309, P310, P311, P312, P313, P314, P319, P320.
- Product
- Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product…
- Recalling firm
- THERAKOS DEVELOPMENT LIMITED
- Quantity
- 11,499 units
- Distribution
- US Nationwide distribution.
- Recall date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)