BEUDAMED
    FDA Enforcement Class II Terminated

    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.

    Recall: Z-1640-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1640-2015
    Event ID
    71178
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard-Allan Scientific Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2015
    Initiation Date
    April 29, 2015
    Classification Date
    May 21, 2015
    Termination Date
    March 9, 2016
    Address
    4481 Campus Dr, N/A, Kalamazoo, MI, 49008-2590, United States

    Description

    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.

    Reason

    Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx.

    Code Info

    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L-Product Codes 44041& 44042. Lot Numbers & EXP Dates: 301362-Jun-2016; 272123-Sep-2015; 317218-Dec-2016; 266312-Jul-2015. Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL , Product Code 9990370, 9990371 & 9990375; Lot Numbers & EXP Dates: 328311-Mar-2017; 324252-Feb-2017; 314543-Dec-2016; 304548-Jul-2016; 289566-Mar-2016; 282598-Dec-2015; 276182-Nov-2015; 267432-Aug-2015; 255776-Apr-2015; 311289-Oct-2016; 299148-Jun-2016; 285035-Feb-2016; 273852-Oct-2015; 263847-Jul-2015; 312363-Oct-2016 & 255325-Apr-2015

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A; IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: Bangladesh, Canada, China, Costa Rica, Dubai, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.

    Quantity

    506 cases = 20 of Product Code 44041; 37 of Product Code 44042; 185 of Product Code 9990370; 92 of Product Code 9990371; 27 of Product Code 9990375