🔍 RecallPedia

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
🏥 Medical Devices Recalled: November 3, 2017 Madison Polymeric Engineering Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Madison Polymeric Engineering
Reason for Recall:
Affected lots may have exceeded its microbial limits.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.".

Product Codes/Lot Numbers:

EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1182-2018

Related Recalls

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.

Madison Polymeric Engineering

Class I - Dangerous

The product is contaminated with Pseudomonas.

Dec 14, 2018 Surgical Instruments View Details →