FDA Medical Device Recalls (openFDA)
Therakos Inc: 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.
- Recall number
- Z-2839-2011
- Recalling firm
- Therakos Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-12-02
- Posted
- 2011-07-19
- Terminated
- 2015-02-19
- Reason
- Cellex Procedural kits may have minor tears in their Tyvek covers.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 110 units
- Distribution
- Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.
- Lot, serial or model codes
- Lot: Y302 Product code: CLXUSA
- 510(k) numbers
- not on file
- PMA numbers
- ["P860003"]
- Product code
- LNR
- Firm FEI
- 2523595
- Firm city
- Raritan
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28