Photopheresis Kit Recalled Due to Incomplete Testing Before Release
Therakos is recalling 15 photopheresis kits because they were released before testing was completed. If used, a drive tube leak could cause illness or injury.
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 for incomplete product testing released prior to validation. Source text indicates potential for illness or injury if drive tube leak occurs, but no illnesses or injuries have been reported.
Plain-English summary
Therakos, Inc. is recalling 15 THERAKOS CELLEX Photopheresis Procedural Kits (Product Code CLXUSA, Lot K307, expiration date February 1, 2023). The kits were distributed in Illinois.
The product was released before all required testing was completed. If the kits are used and a drive tube leak occurs, they may cause illness or injury to patients.
Patients who have received treatment with these kits, healthcare facilities that have the affected kits in inventory, or clinicians who have ordered this product should contact Therakos immediately to arrange for replacement or proper handling. Do not use the affected kits.
The recalled product
- Product
- THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
- Manufacturer
- Therakos, Inc.
- Hazard
Distribution
Distributed in 1 state:
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See all →- HighTherakos CELLEX Photopheresis System Recalled for Tubing Leaks
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