Device 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.
Z-0969-2019
Product summary
- Event
- Event 81971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4800 pads
- Official record key
device-enforcement:Z-0969-2019
Official wording
Reason: The product is contaminated with Pseudomonas.
Code information: Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P
Distribution pattern: Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada
Derived failure modes
-
Microbial contamination
contaminated with Pseudomonas