Events

Rappel de Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped

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 MOOG Medical Devices Group.

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
    72682
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0415-2016
  • Date de mise en oeuvre de l'événement
    2015-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141973
  • 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
    Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
  • Cause
    Potential for leaking between the purple enfit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
  • Action
    MOOG Medical sent an URGENT Field Safety Notice, dated November 20, 2015, to its customer. The letter identified the affected device, provided a description of the problem, and discussed the risk to health. The customer was asked to contact all known distributors and inform them that MOOG Medical will cease production of all its enteral administration sets using ENFit connectors and transition back to the previous revision of the product codes that do not include the ENFit connector (INF0020, INF0500, INF1200, and GR1200). MOOG Medical will produce the previous revision until a solution to the problem is found. All necessary users should be made aware of the notice. Christopher Dodge, Manager, Regulatory Affairs, should be contacted with questions or for additional info at 801-264-1001, ext. 112 or cdodge@moog.com.

Device

Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Tran...
  • Modèle / numéro de série
    All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to the state of MN.
  • Description du dispositif
    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). || Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Adresse du fabricant
    MOOG Medical Devices Group, 4314 S Zevex Park Ln, Salt Lake City UT 84123-7881
  • Société-mère du fabricant (2017)
    Moog Inc
  • Source
    USFDA