Home / Recalls / Madison Polymeric Engineering / Z-0969-2019

Z-0969-2019 Class II Terminated

Recalled by Madison Polymeric Engineering — Branford, CT

Recall Details

Product Type
Devices
Report Date
March 6, 2019
Initiation Date
December 14, 2018
Termination Date
December 31, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4800 pads

Product Description

Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.

Reason for Recall

The product is contaminated with Pseudomonas.

Distribution Pattern

Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada

Code Information

Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P

Other recalls by Madison Polymeric Engineering

  • Z-1925-2019 Class II — First Step Draco Pad, Product Number EP-4D (May 8, 2019)
  • Z-1924-2019 Class II — Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product (May 8, 2019)
  • Z-1898-2018 Class II — First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-1895-2018 Class II — First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean (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-1896-2018 Class II — First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-1897-2018 Class II — First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endosco (March 21, 2018)
  • Z-1900-2018 Class II — Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Dete (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)