Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination
Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
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 is classified as FDA Class II and involves microbial contamination in a medical device used for endoscope pre-cleaning, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Madison Polymeric Engineering is recalling the First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4. The recall involves 1,422 cases containing 99,540 kits. The affected products were distributed to numerous US states, including AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI, as well as Canada.
The recall was initiated because the products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. The affected lot numbers are EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181227P, EX20181228P, EX20181229P, EX20190102P, EX20190103P, EX20190105P, EX20190111P, and EX20190112P.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed above and stop using the affected products.
The recalled product
- Product
- First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
- Manufacturer
- Madison Polymeric Engineering
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 (12)
- Lot Numbers: EX20181220P
- EX20181221P
- EX20181222P
- EX20181226P
- EX20181227P
- EX20181228P
- EX20181229P
- EX20190102P
- EX20190103P
- EX20190105P
- EX20190111P
- EX20190112P
Distribution
Part of a larger recall action
This product is one of 6 recalled by Madison Polymeric Engineering under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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- ModerateMadison Polymeric Engineering Recalls Flexible Endoscope Pre-Clean Kits
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- HighMadison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination
FDA (Devices) · 2018-05-30
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