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Terminated

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.

FDA Recall Z-0969-2019 · Posted None

Recalling FirmMadison Polymeric Engineering
Recall StatusTerminated
Product CodeMNL
Date Initiated2018-12-14
Date Terminated2019-12-31
Product Quantity4800 pads

Reason for Recall

The product is contaminated with Pseudomonas.

Firm 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.

Root Cause

Nonconforming Material/Component

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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