Z-1654-2010

Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx...

Name: Z-1654-2010 Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx...
Creator: Therakos Inc
Published: 2010-03-29
License: https://open.fda.gov/license/

Therakos Inc / initiated 2010-03-29 / Terminated / root cause: manufacturing process

FDA source

Therakos Inc began a recall of Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument on 2010-03-29. The reason FDA records is "Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1654-2010
Status: Terminated
Initiated: 2010-03-29
Posted: 2010-05-26
Terminated: 2013-07-18
Recalling firm: Therakos Inc
Product: Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
Product code: LNR System, Photopheresis, Extracorporeal
Reason for recall: Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System
Root cause tag: manufacturing process
FDA 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 in commerce: 280 units in US (1 sales unit contains 3 kits each)
Distribution: Nationwide Distribution, and Canada and Germany
Product codes and lots: 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

Product code LNR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)