XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH

FDA device recall Z-2994-2011 · posted 2011-08-10 · Terminated

Recall details

Recalling firm

Therakos, Inc.

Reason for recall

Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits.

Action taken

The firm, Therakos Photopheresis, sent a "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated March 31, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue using the affected products; deface and discard their remaining inventory of affected procedural kits, following their internal procedures for destroying and discarding of medical waste, and complete and return the attached Confirmation of Receipt Form no later than 08-April-2011 via fax to: Safety, Risk Management and Surveillance at 1-888-557-3759 or 1-585-453-4110. If you have any additional technical questions, please contact Therakos Customer Service Center at 1-800-828-6316. If you have technical questions regarding this communication, please call Therakos Technical Support at 1-877-865-6850.

Root cause

Device Design

Status

Terminated

Product code

LNR

Quantity affected

13239 kits

Distribution

Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD,TN, TX,

Date initiated

2011-03-31

Date posted

2011-08-10

Date terminated

2015-03-18

Location

Bridgewater, NJ