Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzyma...
FDA Recall #Z-0969-2019 — Class II — December 14, 2018
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.
Recalling Firm
Madison Polymeric Engineering — Branford, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4800 pads
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated