Recall Z-1182-2018— Madison Polymeric Engineering
Class II · Terminated
Class II FDA medical device recall by Madison Polymeric Engineering, initiated 2017-11-03, terminated 2018-07-17. FDA's recall record names no specific 510(k) clearance for this event. 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 working instantly to break down all forms of bioburden.".. Reason: Affected lots may have exceeded its microbial limits..
- Recalling firm
- Madison Polymeric Engineering
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-03
- Terminated
- 2018-07-17
- Firm location
- Branford, CT, United States
Product 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.".
Reason for recall
Affected lots may have exceeded its microbial limits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.