Events

Rappel de Device Recall Irrigation Kit

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 Apogee Medical.

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
    57721
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1035-2011
  • Date de mise en oeuvre de l'événement
    2011-01-18
  • Date de publication de l'événement
    2011-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97083
  • 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
    Lubricant, patient - Product Code KMJ
  • Cause
    This recall has been initiated due to concerns expressed by the food and drug administration regarding the validation of the gamma radiation sterilization cycles for these products of sterile lubricating jelly manufactured by triad group.
  • Action
    The firm, TRIAD Group, sent a "Urgent Medical Device Recall" letter dated January 18, 2010 to all consignees/customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to review there inventory, cease distribution of the affected lots and to complete and return the enclosed Product Recall Response Form via fax to 1-919-570-9611 or e-mail to Apogee Medical. If they distributed the product, they were instructed to notify their customers of the recall; to include a copy of the recall notification, and to instruct them to return the recalled product to the wholesaler who would then return the product to Apogee Medical. Non-responders to the recall notice will be contacted on a weekly basis. Should you have any questions regarding this notification, please call the Regulatory Affairs/Quality Assurance Manager at (919) 435-5409.

Device

Device Recall Irrigation Kit
  • Modèle / numéro de série
    Catalog number: 6111, Lot numbers: 11027, 11119, 11262, 11414, 11695, 11882, 12114, 12271, 12586, 12888, 13080, 13316, 13527, 13548, 13736, 13979, 14091, 14093, 14457, 14732, 14945, 14946, 15781, 15989, 16414, 16424, 16633, 16882, 17016, 17381, 17574, 17576, 17956, 18127, 18475, 19450, 19557.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
  • Description du dispositif
    Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
  • Manufacturer
    Apogee Medical

Manufacturer

Apogee Medical
  • Adresse du fabricant
    Apogee Medical, 90 Hearther Ct, Youngsville NC 27596
  • Source
    USFDA