Events

Rappel de Device Recall Magic3 Hydrophilic 6 French Pediatric

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 Rochester Medical Corp.

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
    51205
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1077-2009
  • Date de mise en oeuvre de l'événement
    2009-01-14
  • Date de publication de l'événement
    2009-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79164
  • 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
    Urological Catheter - Product Code KOD
  • Cause
    Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
  • Action
    Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn. For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.

Device

Device Recall Magic3 Hydrophilic 6 French Pediatric
  • Modèle / numéro de série
    Lot # 53606896
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA including states of CA, FL, GA, ID, IL, LA, MD, MA, MI, MN, NJ, NM, NY, OH, PA, and WA and countries of United Kingdom.
  • Description du dispositif
    Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606 || Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. || Intended for use for bladder management including urine drainage, collection and measurement.
  • Manufacturer
    Rochester Medical Corp

Manufacturer

Rochester Medical Corp
  • Adresse du fabricant
    Rochester Medical Corp, 1 Rochester Medical Dr Nw, Stewartville MN 55976-1647
  • Source
    USFDA