Device Recall ConvaTec

  • Model / Serial
    Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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.
  • Manufacturer