Z-1640-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2015
- Initiation Date
- April 29, 2015
- Termination Date
- March 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Product 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 for Recall
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.
Distribution Pattern
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.
Code Information
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