Events

Rappel de Device Recall WilsonCook Endoscopic Clipping Device

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 Cook Endoscopy.

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
    59039
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2691-2011
  • Date de mise en oeuvre de l'événement
    2011-06-07
  • Date de publication de l'événement
    2011-06-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100882
  • 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
    Ligator, Esophageal - Product Code MND
  • Cause
    The disposable clip may not deploy after being positioned inside the patient.
  • Action
    Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an "URGENT: PRODUCT RECALL" notice dated June 7, 2011 and a "PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. If you have any questions regarding this matter, please contact the Customer Relations Department at toll free-1-800-457-4500, press 4 then enter extension 2146 or by email at CustomerRelationsNA@cookmedical.com .

Device

Device Recall WilsonCook Endoscopic Clipping Device
  • Modèle / numéro de série
    Lot numbers: W2965637, W2976210, W2978497, W2983595, W2986018, W2987394, W2987969, W2990400, and W2998860.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.
  • Description du dispositif
    Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical || Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Adresse du fabricant
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA