FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0969-2019
- Recalling firm
- Madison Polymeric Engineering
- 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.
- Status
- Terminated
- Initiated
- 2018-12-14
- Posted
- not on file
- Terminated
- 2019-12-31
- 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
- Lot, serial or model codes
- Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 3001451466
- Firm city
- Branford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28