The Recall Desk

FDA (Devices) recall action 79826

Madison Polymeric Engineering recalled 6 products on 2018-05-30

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2018-05-30
Critical
0
Units
—

Why these products were recalled

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2018-05-30

    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.

    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)
    Category
    Distribution
    40 states
  • ModerateFDA (Devices)··2018-05-30

    Madison Polymeric Engineering Recalls Draco Enzymatic Deep-Cleaning Pads

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
    Category
    Distribution
    40 states