Recall Z-2994-2011 ยท LNR System, Photopheresis, Extracorporeal
Therakos, Inc.
XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patien
| Date | Aug 10, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits. |
| Root cause | Device Design |
| Action | 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 1-888-55 |
| Quantity | 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, UT, VA, VT, WA, and WI; and countries of: Argentina, Austria, Australia, Belgium, Canada, Denmark, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.