Recall Z-0969-2019— Madison Polymeric Engineering
Class II · Terminated
Class II FDA medical device recall by Madison Polymeric Engineering, initiated 2018-12-14, terminated 2019-12-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Madison Polymeric Engineering
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-14
- Terminated
- 2019-12-31
- Firm location
- Branford, CT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.