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Terminated

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.

FDA Recall Z-2839-2011 · Posted 2011-07-19

Recalling FirmTherakos Inc
Recall StatusTerminated
Product CodeLNR
Date Initiated2010-12-02
Date Terminated2015-02-19
Product Quantity110 units

Reason for Recall

Cellex Procedural kits may have minor tears in their Tyvek covers.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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