Events

Rappel de Cook Medical Ciaglia Blue Dolphin

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, 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
    56084
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2080-2010
  • Date de mise en oeuvre de l'événement
    2010-04-21
  • Date de publication de l'événement
    2010-07-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92626
  • 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
    Percutaneous Tracheostomy Introducer Set - Product Code JOH
  • Cause
    These set and/or tray products are being recalled because they include a covidien shiley 6perc or covidien shiley 8perc tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.
  • Action
    Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately.

Device

Cook Medical Ciaglia Blue Dolphin
  • Modèle / numéro de série
    2451349, 2328599, 2455952, 2330814, 2336324, 2260563, 2320508, 2242064, 2289456, 2330816, 2301524, 2260561, 2393721, 2305091, 2316113, 2305089, 2417210, 2313166, 2343922, 2289454, 2301526, 2377273, 2336320, 2440350, 2236964, 2443067, 2328597, 2316115, 2298767, 2354683, 2285639, 2254641, 2280164, 2305087, 2336322, 2440352, 2236966, 2229876, 2364739, 2316117, 2285637, 2373622, 2280166, 2254638, 2316118, 2359778, 2382675, 2310206, 2343924, 2348175, 2451351, 2272949, 2328600, 2364737, 2298768, 2320506, 2354685, 2268131, 2272946, 2348177, 2310204, 2247510, 2247509, 2364740, 2242063, 2451347, 2447611, 2373624, 2268133, 2377274, 2247512, 2242061, 2455951, 2289453, 2348178, 2330815, 2359776, 2382673, 2447613, 2451348, 2328598, 2455953, 2330817, 2301525, 2298770, 2417209, 2313168, 2260562, 2320509, 2242065, 2305088, 2343923, 2417211, 2301527, 2377272, 2336321, 2260560, 2305090, 2359780, 2316114, 2354682, 2285638, 2280165, 2313167, 2343921, 2289455, 2336323, 2440351, 2236965, 2316116, 2285636, 2254640, 2280167, 2373623, 2313165, 2260564, 2364738, 2359779, 2373621, 2382674, 2447614, 2254642, 2343925, 2451350, 2254639, 2328601, 2272948, 2455954, 2409902, 2354684, 2280168, 2440349, 2268130, 2247511, 2247508, 2236963, 2242062, 2298769, 2461159, 2320507, 2268132, 2272947, 2348176, 2310205, 2285640, 2364741, 2320505, 2289452, 2348179, 2359777, 2268134, 2382672, 2447612, 2377275, 2310203, 2272945, 2443068, 2443070, and 2443069.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay.
  • Description du dispositif
    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Adresse du fabricant
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA