Madison Polymeric Engineering Recalls Flexible Endoscope Pre-Clean Kits
Madison Polymeric Engineering is recalling First Step EP-4 Flexible Endoscope Bedside Pre-Clean Kits due to microbial contamination with Yarrowia lipolytica.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is microbial contamination causing an odor, with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Madison Polymeric Engineering is recalling the Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W). The recall involves 23 cases containing 1,150 kits.
The products are being recalled because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. The affected lot numbers are EX20190103P, EX20190105P, EX20190111P, EX20190112P, EX20181220P, EX20181227P, EX20181228P, and EX20181229P.
The products were distributed to facilities in the following US states: 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. The products were also distributed in Canada. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
- 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 (8)
- Lot Numbers: EX20190103P
- EX20190105P
- EX20190111P
- EX20190112P
- EX20181220P
- EX20181227P
- EX20181228P
- EX20181229P
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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