The Recall Desk

FDA (Devices) recall action 65879

Convatec Inc. recalled 2 products on 2013-08-28

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-08-28
Critical
0
Units
45,792

Why these products were recalled

ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Devices)··2013-08-28

    ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error

    Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.

    Product
    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2013-08-28

    ConvaTec Flexi-Seal Fecal Management System Recalled for Packaging Error

    Convatec is recalling Flexi-Seal Signal Fecal Management Systems because the lot number convention was duplicated on the packaging for certain lots.

    Product
    ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Distribution
    0 states