Therakos Cellex Procedural Kits recallZ-2839-2011 · Therakos Inc · initiated Dec 2, 2010
Terminated All recalls posted in July 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Therakos Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cellex Procedural kits may have minor tears in their Tyvek covers.
FDA root cause category: Employee error
What the company is doing
Therakos, Inc. sent an "Important Product Notification" dated December 2, 2010 to all affected customers. The letter included description of problem, affected lot and recommendations. Customers were asked to dispose any product with affected lot and to contact them for for replacement, and to complete and return the attached Fax reply form. For additional information contact Therakos Customer Technical Services at 877-865-6850.
Recall details
- Recall number
- Z-2839-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 2, 2010
- Posted by the FDA
- Jul 19, 2011
- Recalling firm
- Therakos Inc
- Quantity
- 110 units
- Product code
- LNR
- FDA submissions
- P860003
- Distribution
- Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.
Product description
Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
Code information (models, lots, serial numbers)
Lot: Y302 Product code: CLXUSA
Other devices under the same FDA submission
2 devices cleared under P860003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CELLEX CLXSP-ITherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL23 reports
- CELLEX CLXCC-ITherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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