Events

Rappel de Device Recall Infusion Administration Set

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 Zevex International, Inc..

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
    57829
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1447-2011
  • Date de mise en oeuvre de l'événement
    2011-01-24
  • Date de publication de l'événement
    2011-02-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97564
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    Defect in tubing may trigger false air-in-line warning.
  • Action
    The firm, MOOG, sent an "Expansion of Moog/Curlin Ambulatory Pump Administration Set Recall" letter dated May 2, 2011 to its customers. This letter informed the customers that this recall has been expanded to included specific lot numbers of Curlin model ambulatory infusion administration sets. The customers were instructed to follow the outlined process in the letter: remove suspect product code from inventory, contact MOOG Customer Service at 1-800-970-2337, prompt #7, contact your distributor to arrange replacement product, request a shipping return label as per the distributor's process and ship back to their location and follow the temporary solution outlined in the letter. Moog Customer Service will provide a call tag for convenient product return. If you have any questions contact MOOG Customer Service at 1-800-970-2337. The firm, MOOG, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 24, 2011 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to remove suspect product code from inventory; contact their distributor to arrange replacement product, if purchased from distributor and request shipping return label per distributors process and ship back to their location or contact MOOG Customer Service at 800-970-2337, prompt #7, if purchased directly from MOOG and MOOG Customer Service will provide a call tag for convenient product return; follow the temporary solution provided until replacements are administered; and complete and return the MEDICAL DEVICE CORRECTION REPLY FORM in the self addressed envelope provided. If you have any questions, contact MOOG Customer Service at 800-970-2337.

Device

Device Recall Infusion Administration Set
  • Modèle / numéro de série
    ***EXPANDED*** Additional Lots Added 05/12/2011: CF1026704, CRF10097001.  Lot Codes: CF1020102, CF1020103, CRF10098001, CRF10144001, CRF10145001, D005005, D005014, D009501, D010305, D010319, D011110, D011111, D013442, D014706, D017318, D017420, D017421, D018005, D019321, D019322, D020235, D020923, D020924, D021404, D022201, D022202, D022203, D024921, D024922.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.
  • Description du dispositif
    Curlin Infusion Administration Set, REF 340-4130-V, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • Adresse du fabricant
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • Société-mère du fabricant (2017)
    Moog Inc
  • Source
    USFDA