Z-0969-2019Class II

Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z

Name: Z-0969-2019 Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z
Creator: Madison Polymeric Engineering
Published: 2018-12-14
License: https://open.fda.gov/license/

Madison Polymeric Engineering / initiated 2018-12-14 / Terminated / root cause: manufacturing process

FDA source

Madison Polymeric Engineering began a recall of Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease... on 2018-12-14. FDA classified it as Class II and gives the reason as "The product is contaminated with Pseudomonas". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0969-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-14
Posted: 2019-02-28
Terminated: 2019-12-31
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.
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: The product is contaminated with Pseudomonas.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0969-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0969-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-28

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)