FDA Device recall Z-0969-2019
Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, a…
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, a… by Madison Polymeric Engineering, citing the product is contaminated with Pseudomonas.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0969-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-14 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Madison Polymeric Engineering |
| Distribution | CA, FL, IL, IN, NJ, NY, PA, TN |
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.
Reason
The product is contaminated with Pseudomonas.
Identifiers
| code_info | Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0969-2019%22
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