| Class 2 Device Recall THERAKOS UVAR XTS Procedural Kits | |
Date Initiated by Firm | March 31, 2011 |
Date Posted | August 10, 2011 |
Recall Status1 |
Terminated 3 on March 18, 2015 |
Recall Number | Z-2994-2011 |
Recall Event ID |
58744 |
PMA Number | P860003S031 P860003S051 |
Product Classification |
System, photopheresis, extracorporeal - Product Code LNR
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Product | 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 patient. |
Code Information |
XT125 Procedural Kit (X752-X760 and Y701-Y753) and XT001 Procedural Kit (X919 and Y901-Y911) |
Recalling Firm/ Manufacturer |
Therakos, Inc. 440 Us Highway 22 Ste 140 Bridgewater NJ 08807-2477
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For Additional Information Contact | Joe Falvo 908-367-5447 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 1-888-557-3759 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. |
Quantity in Commerce | 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, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Kingdom of Saudi Arabia, Jordan, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LNR
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