Events

Rappel de Device Recall PD Access Vascular Access 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 Escalon Medical Corp.

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
    56610
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0132-2011
  • Date de mise en oeuvre de l'événement
    2010-05-05
  • Date de publication de l'événement
    2010-10-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94089
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Cause
    The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. use of a non-sterile product increases risk of patient infection. this recall involes: model 78050 18 gauge pd access vascular access device, model 78060 extended 18 gauge pd access vascular access device, model 75010 18 gauge smartneedle vascular access devices with expiration da.
  • Action
    Escalon Vascular Access issued an "Urgent: Recall" letter dated May 5, 2010 to customers. The letter identified the affected product being recalled, described the problem, and the actions to be taken.. Consignees were recommended to immediately examine their inventory, quarantine the product, notify their customers, and return product affected. They also advised them that if they have further distributed the product, to please identify the customers and notify them at once of the product recall. Replacement product can be ordered from Vascular Solutions, Inc at 888-240-6001. Customer service can be contacted at 800-676-0043.

Device

Device Recall PD Access Vascular Access Device
  • Modèle / numéro de série
    78050 Starting with lot 1335050157 exp date 2010-04 Ending with lot 1469100138 exp date 2015-03  78060 Starting with lot 1335050222 exp date 2010-04 Ending with lot 1470100140 exp date 2015-03   75010 Starting with lot 1337050271 exp date 2010-05 Ending with lot 1469100139 exp date 2015-03
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of AL, AR, AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD.MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, MN, NY, NC, ND, OH, OK OR, PA, RI, SC, SD,TN, TX UT, VA, WA, WV, and WI, and the countries of: Australia, Austria, Bahamas, Canada, Colombia, Denmark, England, Germany, Greece, Hong Kong, Italy, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, and Switzerland.
  • Description du dispositif
    PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: || Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device. || Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device || Model 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices
  • Manufacturer
    Escalon Medical Corp

Manufacturer

Escalon Medical Corp
  • Adresse du fabricant
    Escalon Medical Corp, 2440 S 179th St, New Berlin WI 53146-2149
  • Société-mère du fabricant (2017)
    Escalon Medical Corp
  • Source
    USFDA