FDA Enforcement
Class II
Terminated
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.
Recall: Z-0969-2019
·
Reported March 6, 2019
Enforcement
- Recall Number
- Z-0969-2019
- Event ID
- 81971
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Madison Polymeric Engineering
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2019
- Initiation Date
- December 14, 2018
- Classification Date
- February 28, 2019
- Termination Date
- December 31, 2019
- Address
- 965 W Main St, Branford, CT, 06405-3453, United States
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
The product is contaminated with Pseudomonas.
Code Info
Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P
Distribution
Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada
Quantity
4800 pads