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
- Recall Number
- Z-0969-2019
- Event Number
- 81971
- Firm
- Madison Polymeric Engineering
- FEI Number
- 3001451466
- Product Code
- MNL
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 14, 2018
- Terminated
- December 31, 2019
- Address
- 965 W Main St, Branford, CT, 06405-3453
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.
The product is contaminated with Pseudomonas.
Cygnus sent an Urgent Medical Device Recall notification letters dated December 14, 2018 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 800-990-7489.
Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada
4800 pads