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.
This recall has been terminated (originally issued December 14, 2018).
- Company
- Madison Polymeric Engineering
- Recall Initiated
- December 14, 2018
- Terminated
- December 31, 2019
- Recall Number
- Z-0969-2019
- Quantity
- 4800 pads
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
The product is contaminated with Pseudomonas.
Distribution
Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada
Lot / Code Info
Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P
Root Cause
Nonconforming Material/Component
Action Taken
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.
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