🔍 RecallPedia

Madison Polymeric Engineering

11 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Surgical Instruments

First Step Draco Pad, Product Number EP-4D

Class I - Dangerous

This product has been contaminated with Stenotrophomonas lactiubi.

May 8, 2019 Other Medical Devices View Details →

Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

Class I - Dangerous

This product has been contaminated with Stenotrophomonas lactiubi.

May 8, 2019 Other Medical Devices View Details →

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.

Class I - Dangerous

The product is contaminated with Pseudomonas.

Dec 14, 2018 Surgical Instruments View Details →

First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3

Class I - Dangerous

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Mar 21, 2018 Other Medical Devices Nationwide View Details →

Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)

Class I - Dangerous

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Mar 21, 2018 Other Medical Devices Nationwide View Details →

First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4

Class I - Dangerous

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Mar 21, 2018 Other Medical Devices Nationwide View Details →

First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6

Class I - Dangerous

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Mar 21, 2018 Other Medical Devices Nationwide View Details →

First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B

Class I - Dangerous

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Mar 21, 2018 Other Medical Devices Nationwide View Details →

Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z

Class I - Dangerous

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Mar 21, 2018 Other Medical Devices Nationwide View Details →

First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

Class I - Dangerous

Affected lots may have exceeded its microbial limits.

Nov 3, 2017 Surgical Instruments View Details →

Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

Class I - Dangerous

Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.

Apr 17, 2017 Other Medical Devices View Details →