Events

Rappel de Device Recall Cook Medical

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
    73056
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0799-2016
  • Date de mise en oeuvre de l'événement
    2016-01-06
  • Date de publication de l'événement
    2016-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142930
  • 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, percutaneous - Product Code DQY
  • Cause
    A manufacturing process may lead to catheter tip fracture and or separation. potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. these catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
  • Action
    On 1/6/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

Device

Device Recall Cook Medical
  • Modèle / numéro de série
    RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH C-PMSY-301J-PED C-PMSY-301J-PED-OTP C-PMSY-400-HURLEY-022388 C-PUM-300J C-PUM-301 C-PUM-301J C-PUMY-301J  Lots: NS6168054 NS6178118 NS6063352 NS5855441 5824486 5898058 5967405 6079119 NS5932737 NS6028554 NS6042799 NS5922707 NS5932811 NS6145002 5987014 NS6178099 NS6028540 NS5830758 NS5866960 NS5918174 NS5974263 NS6042577 NS6047450 NS6090278 NS6105922 NS6124990 NS5881337 NS5892116 NS6031991 5782006 5855241 NS5881336 NS5892113 NS5945282 6062729 NS5970950 NS6108255 NS6153173 5793198 5925744 6010406 6148800 NS5796483 NS5928602 NS6047451 NS5970942 NS5954223 5945120 NS5954224 5973354
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
  • Description du dispositif
    Single Lumen Central Venous Catheter Sets and Trays || The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA