Events

Rappel de Device Recall SenSura and Assura Postop Pouches

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 Coloplast Manufacturing US, LLC.

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
    59564
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3174-2011
  • Date de mise en oeuvre de l'événement
    2011-07-27
  • Date de publication de l'événement
    2011-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103087
  • 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
    Collector, ostomy - Product Code EXB
  • Cause
    On july 19, 2011 coloplast became aware of the failure or routine sterility testing for one lot of sensuera and assura post-op ostomy bags. based on these results it was determined that all affected lots be recalled and quarantined. this affects lots manufactured and distributed from january 2010 until july 19, 2011.
  • Action
    Coloplast sent a "RECALL OF STERILE SENSURA AND ASSURE POST-OP POUCHES" letter dated July 27, 2011 to all affected customers. An enclosed Field Safety Notice described the product, problem, and actions to be taken by the customers. Contact your Customer Service representative at 800-533-0464 for questions regarding this recall.

Device

Device Recall SenSura and Assura Postop Pouches
  • Modèle / numéro de série
    Item code Lot. No 1280801400 2460849 1280801400 2467727 1280801400 2478730 1280801400 2487494 1280801400 2642633 1280801400 2694739 1280801400 2881701 1280801400 2899205 1281001400 2286634 1281001400 2442838 1281001400 2460851 1281001400 2467729 1281001400 2478732 1281001400 2494667 1281001400 2504331 1281001400 2517312 1281001400 2528041 1281001400 2542226 1281001400 2581246 1281001400 2597087 1281001400 2717298 1281001400 2740701 1281001400 2801394 1281001400 2818921 1281001400 2835494 1281001400 2858099 1281001400 2881703 1281001400 2899207 1281801400 2494669 1281801400 2528043 1281801400 2589985 1281801400 2771851 1900101400 2744870 1900101400 2897575 1900101400 2910204 1900101400 2913671 1901001400 2785864 1901001400 2928713 1901101400 2785865 1901101400 2928714 1901101400 2932901
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, GA, LA, MA, MD, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, and WI.
  • Description du dispositif
    Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.) || Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark. || These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Adresse du fabricant
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Société-mère du fabricant (2017)
    Coloplast A/S
  • Source
    USFDA