Madison Polymeric Engineering Recalls First Step Flexible Endoscope Bedside Pre-Clean Kit
Madison Polymeric Engineering is recalling 285 cases of the First Step Flexible Endoscope Bedside Pre-Clean Kit because affected lots may have exceeded microbial limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard (exceeding microbial limits) is present, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Madison Polymeric Engineering is recalling 285 cases of the First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. The product is intended for the pre-cleaning of the outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection.
The recall was initiated because affected lots may have exceeded their microbial limits. The specific lots involved are EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A, and EP-4D Lot EXP20 l80520A.
The product was distributed in the United States. The source text does not specify further distribution details or report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- 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
- Manufacturer
- Madison Polymeric Engineering
- Hazard
- Affected units
- 285
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 (3)
- EP-4 Lots EXP20 l 7 l 209A
- EXP20 l 80512A
- and EP-4D Lot EXP20 l80520A
Distribution
Distribution scope not specified by the agency.
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