Recall Z-0969-2019 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Madison Polymeric Engineering
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.
| Date | Dec 14, 2018 |
| Status | Terminated |
| Reason | The product is contaminated with Pseudomonas. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.