Home / Recalls / Madison Polymeric Engineering / Z-1896-2018

Z-1896-2018 Class II Terminated

Recalled by Madison Polymeric Engineering — Branford, CT

Recall Details

Product Type
Devices
Report Date
May 30, 2018
Initiation Date
March 21, 2018
Termination Date
April 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1422 cases/99540 kits

Product Description

First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4

Reason for Recall

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Distribution Pattern

The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.

Code Information

Lot Numbers: EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181227P, EX20181228P, EX20181229P, EX20190102P, EX20190103P, EX20190105P, EX20190111P, EX20190112P

Other recalls by Madison Polymeric Engineering

  • Z-1924-2019 Class II — Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product (May 8, 2019)
  • Z-1925-2019 Class II — First Step Draco Pad, Product Number EP-4D (May 8, 2019)
  • Z-0969-2019 Class II — Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Mu (December 14, 2018)
  • Z-1897-2018 Class II — First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endosco (March 21, 2018)
  • Z-1899-2018 Class II — Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexibl (March 21, 2018)
  • Z-1895-2018 Class II — First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-1900-2018 Class II — Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Dete (March 21, 2018)
  • Z-1898-2018 Class II — First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-1182-2018 Class II — First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clea (November 3, 2017)
  • Z-2211-2017 Class II — Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY (April 17, 2017)