The Recall Desk
ModerateFDA (Devices)·Z-0969-2019·Announced 2019-03-06

Draco Enzymatic Deep-Cleaning Pads recalled due to Pseudomonas contamination

The FDA issued recall Z-0969-2019 for Draco Enzymatic Deep-Cleaning Pads because they were found contaminated with Pseudomonas bacteria.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: No illnesses or injuries have been reported despite the Pseudomonas contamination. Per the severity rubric, low-risk contamination without documented harm qualifies as Moderate severity (score 2). The agency classification is FDA Class II, which supports a minimum severity of 2.

Plain-English summary

The U.S. Food and Drug Administration issued recall Z-0969-2019 for Draco Enzymatic Deep-Cleaning Pads (Product Number HY0305Z). The product was found contaminated with Pseudomonas, a bacterial pathogen. The recall applies worldwide including the United States and Canada. Consumers are advised to stop using the product immediately and dispose of it safely. The manufacturer Madison Polymeric Engineering should remove the affected inventory from sale.

The product is a multi-tiered enzymatic detergent designed for dissolving organic materials such as blood, fat, tissue, and protein. While the product itself is non-toxic and latex-free, the presence of Pseudomonas represents a potential infection risk if the product comes into contact with sterile medical equipment. Because no illnesses or injuries have been reported and the recall is classified as a voluntary precautionary action, the severity is assessed as moderate.

Affected lot numbers include EX20190419P through EX20190424P. Consumers should return unused product to the manufacturer for proper disposal. The recall does not affect the safety of the enzyme components themselves, but the microbial contamination requires removal from clinical use until further testing confirms the issue is resolved.

The recalled product

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-toxi
Manufacturer
Madison Polymeric Engineering
Category
Medical Device — Enzymatic Cleaning Pads
Hazard
Affected units
4,800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P

Distribution

Distributed in 8 states:

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