Cellex photopheresis kit centrifuge bowls may dislodge and break
Cellex Photopheresis Kits are being recalled because the centrifuge bowl is harder to install and, if fitted improperly, may dislodge and break during priming or treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall where a broken centrifuge bowl can delay treatment and cause blood loss, a risk of harm with no injuries reported in the source.
Plain-English summary
The CELLEX Photopheresis Kit, model/catalog number CLXUSA, UDI-DI 20705030200003, is being recalled. The kit is used with the Cellex Photopheresis System for extracorporeal photopheresis, a photoimmune therapy in which leukocytes are separated from the blood. The action covers 5,826 units across lots N301 and N339 to N347.
There is increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. According to the manufacturer, 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 FDA classified the action as Class II.
Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, UDI-DI and lot numbers above, quarantine it, and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- THERAKOS DEVELOPMENT LIMITED
- Affected units
- 11,499
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 (20)
- 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
Distribution
Distributed nationwide across the United States.
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