BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0132-2011 · Initiated May 5, 2010

    Recall

    Recall Number
    Z-0132-2011
    Event Number
    56610
    Firm
    Escalon Medical Corp
    FEI Number
    2183477
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 5, 2010
    Posted
    October 22, 2010
    Terminated
    March 28, 2013
    Address
    2440 S 179th St, New Berlin, WI, 53146-2149

    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

    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.

    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.

    Quantity

    188,375