Z-2839-2011

Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell...

Name: Z-2839-2011 Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell...
Creator: Therakos Inc
Published: 2010-12-02
License: https://open.fda.gov/license/

Therakos Inc / initiated 2010-12-02 / Terminated / root cause: manufacturing process

FDA source

Therakos Inc began a recall of Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed... on 2010-12-02. The reason FDA records is "Cellex Procedural kits may have minor tears in their Tyvek covers". 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-2839-2011
Status: Terminated
Initiated: 2010-12-02
Posted: 2011-07-19
Terminated: 2015-02-19
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.
Product code: LNR System, Photopheresis, Extracorporeal
Reason for recall: Cellex Procedural kits may have minor tears in their Tyvek covers.
Root cause tag: manufacturing process
FDA 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 in commerce: 110 units
Distribution: Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.
Product codes and lots: Lot: Y302 Product code: CLXUSA

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)