The Recall Desk

FDA (Devices) recall action 81244

Ecolab Inc recalled 4 products on 2018-10-31

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-10-31
Critical
0
Units
—

Why these products were recalled

The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.

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

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2018-10-31

    Ecolab Recalls Da Vinci Robotic System Disposable Accessory Kits

    Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.

    Product
    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to co
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2018-10-31

    Ecolab Recalls Disposable Accessory Kits for Da Vinci Robotic System

    Ecolab Inc is recalling specific lots of Disposable Accessory Kits, 3-Arm, due to potential pouch seal defects that could compromise sterility.

    Product
    Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to co
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2018-10-31

    Ecolab recalls sterile instrument arm drapes due to potential seal defects

    Ecolab is recalling specific lots of sterile instrument arm drapes for the Da Vinci Si system because seal wrinkles may compromise sterility.

    Product
    Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap vari
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2018-10-31

    Ecolab Camera Arm Drapes Recalled for Potential Sterility Breach

    Ecolab is recalling specific lots of Camera Arm Drapes because wrinkles in the packaging seal could compromise the product's sterility.

    Product
    Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap vario
    Category
    Distribution
    49 states