Events

Rappel de Device Recall Catheter Insertion 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, 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
    58278
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2133-2011
  • Date de mise en oeuvre de l'événement
    2011-03-24
  • Date de publication de l'événement
    2011-05-03
  • 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=98876
  • 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
    Catheter care tray - Product Code OHR
  • Cause
    Kits contain pvp (providone iodine) prep pads that are being recalled by the triad group due to possible micro contamination, elizabethkingia meningoseptica.
  • Action
    The firm, Apogee Medical LLC, sent an "Urgent Medical Device Recall" letter dated March 23, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their inventory; complete and return the enclosed Product Recall Response Form as soon as possible via fax to (919) 570-9611, mail to: Apogee Medical LLC, Youngsville Commerce Center, 90 Weathers Street, Youngsville, MC 27596, or e-mail to: dpeper@apogeemed.com; cease further distribution and return any product that is the subject of this recall to Apogee Medical LLC. All returned product must be labeled with a returned goods authorization label that has been provided with the letter. Apogee will replace returned product upon receipt of the Product Recall Response Form and identified product. In addition, if the customer distributed the product, they are to identify their customer(s) and notify them at once of this product recall. The notification should include a copy of the this recall notification letter and should instruct the customer to return the recalled product so that it can be returned to Apogee. Should you have any questions regarding this notification, please call the Manager Regulatory Affairs/Quality Assurance at (919) 435-5409.

Device

Device Recall Catheter Insertion Kit
  • Modèle / numéro de série
    Catalog Reference number: 6100A, Lot numbers: 8315, 9317, 0317, 9G176, 0C046, 0G226, 0K186, 1A316, 8316, 9318, 0318, 9G206, 0C086, 0G236, 0K196, 1B016, 8317, 9320, 0319, 9G236, 0C096, 0G246, 0K206, 1B026, 8319, 9321, 0320, 9G286, 0C106, 0G296, 0K226, 1B036, 8320, 9324, 0321, 9G296, 0C186, 0G306, 0K236, 1B046, 8321, 9325, 0322, 9H066, 0C196, 0H216, 0K246, 1B056, 8324, 9326, 0323, 9H076, 0C206, 0H226, 0K256, 1B076, 8325, 9327, 0324, 9H086, 0C226, 0H266, 0K286, 1B186, 8326, 9328, 0325, 9H126, 0C236, 0H276, 0K296, 1B196, 8327, 9329, 0326, 9H176, 0C256, 0H286, 0K306, 1B176, 8329, 9340, 0327, 9H236, 0C266, 0I166, 0L036, 1B196, 8340, 0301, 0328, 9H246, 0C276, 0I176, 0L046, 1B216, 8341, 0302, 0329, 9H256, 0D076, 0I186, 0L066, 1B226, 8342, 0303, 0330, 0A186, 0D086, 0I206, 0L076, 1B236, 9301, 0304, 0331, 0A196, 0D096,0I256, 0L086, 1C016, 9302, 0305, 0332, 0A206, 0D106, 0I276, 0L096, 1C026, 9304, 0306, 1302, 0A216, 0D126, 0J236, 0L226, 1C036, 9305, 0307, 1303, 0A226, 0E086, 0J256, A196 and 1C046.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NJ, NY, OH, OK, TN, TX, VA and WA.
  • Description du dispositif
    Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). || Intended usage: Kit components to be used during Intermittent Urinary Catheterizations
  • Manufacturer
    Apogee Medical, Inc

Manufacturer

Apogee Medical, Inc
  • Adresse du fabricant
    Apogee Medical, Inc, 90 Weathers St., Youngsville NC 27596-7801
  • Source
    USFDA