Medical device recalls Moderate risk

Madison Polymeric Engineering recalls Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lip…

Recall date
December 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0969-2019
FDA classification
Class II
Brand / firm
Madison Polymeric Engineering
Sold / distributed
Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada

Why it was recalled

The product is contaminated with Pseudomonas.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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