Events

Rappel de Device Recall Compat Nasogastric Feeding Tube

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 Nestle HealthCare Nutrition.

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
    65781
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1922-2013
  • Date de mise en oeuvre de l'événement
    2013-07-24
  • Date de publication de l'événement
    2013-08-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120128
  • 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
    Tube, feeding - Product Code FPD
  • Cause
    Nestle healthcare nutrition, inc. is initiating a recall on some of compat ng tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
  • Action
    Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form. For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.

Device

Device Recall Compat Nasogastric Feeding Tube
  • Modèle / numéro de série
    REF 08310400 - Compat¿ Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G  02412K 08211Z 08712W 14212U 14611P 21512Y 35411H  REF 08310500- Compat¿ Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N  04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U  REF 08310600 - Compat¿ Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
  • Description du dispositif
    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). || Product Usage: || The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
  • Manufacturer
    Nestle HealthCare Nutrition

Manufacturer

Nestle HealthCare Nutrition
  • Adresse du fabricant
    Nestle HealthCare Nutrition, 12500 Whitewater Dr, Minnetonka MN 55343-9420
  • Société-mère du fabricant (2017)
    Nestlé S.A.
  • Source
    USFDA