Events

Recall of Device Recall PD Access Vascular Access Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Escalon Medical Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56610
  • Event Risk Class
    Class 2
  • Event Number
    Z-0132-2011
  • Event Initiated Date
    2010-05-05
  • Event Date Posted
    2010-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94089
  • Notes / Alerts
    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.
  • Extra notes in the data
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Escalon Medical Corp, 2440 S 179th St, New Berlin WI 53146-2149
  • Manufacturer Parent Company (2017)
    Escalon Medical Corp
  • Source
    USFDA