FDA Medical Device Recalls (openFDA)
Therakos Inc: Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
- Recall number
- Z-1654-2010
- Recalling firm
- Therakos Inc
- Product
- Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
- Status
- Terminated
- Initiated
- 2010-03-29
- Posted
- 2010-05-26
- Terminated
- 2013-07-18
- Reason
- Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System
- Root cause
- Nonconforming Material/Component
- Action
- On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter. On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall. Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.
- Quantity
- 280 units in US (1 sales unit contains 3 kits each)
- Distribution
- Nationwide Distribution, and Canada and Germany
- Lot, serial or model codes
- CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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