Events

Rappel de CC cartridges for IRMA TRUPOINT Blood Gas Analyzer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par LifeHealth, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72305
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0159-2016
  • Date de mise en oeuvre de l'événement
    2015-09-16
  • Date de publication de l'événement
    2015-10-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140532
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    May report values outside the published performance specifications for ph. after a certain point in shelf life, the ph sensor may give results that are falsely elevated. the discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
  • Action
    Consignees were sent a LifeHealth "Urgent Medical Device Recall" letter dated September 16, 2015. The letter described the problem and the product involved in the recall. The letter described the Risk to Health, Action to be taken and Other Information. Consignees were advised to discontinue use and destroy all stock on hand. Requested consignees to complete and return the Verification Form to LifeHealth. For additional information contact Nancy Ring at 1-855-762-8978 or 651-638-1000, Monday through Friday, 8:30 AM to 4:30 PM, Central Time or see our website at www.lifehealthmed.com.

Device

CC cartridges for IRMA TRUPOINT Blood Gas Analyzer
  • Modèle / numéro de série
    ASBEZ ASCXE ASEMB ASHWQ ASJMY ASLGI ASMXR ASOQO ASRXC ASTQR ASWZI
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US: Nationwide (AL, AR, CA, CO, FL, IL, IN, IA, KS, KY, MD, MA,MI, MN, MS, MO, NE, NJ, NY,NC, OH, OK, PA, TN, TX, VA) OUS: ALBANIA, BELGIUM, BOLIVIA, CANADA, CHILE, CHINA, DENMARK. DOMINICAN REPUBLIC, ECUADOR, EGYPT, ENGLAND, ESTONIA, PHILIPPINES, FRANCE, GERMANY, GREECE, ICELAND, INDONESIA, IRELAND, ITALY, JAMAICA, JAPAN, MOROCCO, NETHERLANDS, NORWAY, PERU, PORTUGAL, SOUTH AFRICA, SOUTH KOREA, SPAIN, TAIWAN, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VIETNAM.
  • Description du dispositif
    CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. || The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
  • Manufacturer
    LifeHealth, LLC

Manufacturer

LifeHealth, LLC
  • Adresse du fabricant
    LifeHealth, LLC, 2656 Patton Rd, Roseville MN 55113-1136
  • Société-mère du fabricant (2017)
    Lifehealth Llc
  • Source
    USFDA