Madison Polymeric Engineering: Medical Device Recall in 2019 - (Recall #: Z-0969-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 14, 2018

Date Posted: March 6, 2019

Recall Number: Z-0969-2019

Event ID: 81971

Reason for Recall:

The product is contaminated with Pseudomonas.

Status: Terminated

Product Quantity: 4800 pads

Code Information:

Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P

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

Voluntary or Mandated:

Voluntary: Firm initiated