BEUDAMED
    FDA Enforcement Class II Ongoing

    20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

    Recall: Z-0921-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0921-2022
    Event ID
    89760
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    March 11, 2022
    Classification Date
    April 13, 2022
    Address
    26531 Ynez Rd, N/A, Temecula, CA, 92591-4630, United States

    Description

    20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

    Reason

    Due to an increase in complaint trend for leaks and intermittent/loose connections.

    Code Info

    Part Numbers: 1000184 Device Identifier-GTIN: 08717648013591 Lot Numbers: 60309678 60320071 60337162 60311336 60320899 60337166 60311338 60331726 60311337 60311339 60331727 60317539 60315914 60334491 60318209 60317535 60334492

    Distribution

    U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama

    Quantity

    17 lots