Recall Z-1896-2018— Madison Polymeric Engineering
Class II · Terminated
Class II FDA medical device recall by Madison Polymeric Engineering, initiated 2018-03-21, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4. Reason: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica..
- Recalling firm
- Madison Polymeric Engineering
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-21
- Terminated
- 2019-04-09
- Firm location
- Branford, CT, United States
Product description
First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
Reason for recall
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Data sourced from openFDA. This site is unofficial and independent of the FDA.