Convatec Fecal Management System

• 2 recalls, same reason

  • Terminated Z-1991-2013 FDA Class III ·initiated 25 Jun 2013
  • Terminated Z-1990-2013 FDA Class III ·initiated 25 Jun 2013

  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.

• • Terminated Z-0618-2009 FDA Unclassified (pre-2012) ·initiated 20 Nov 2008

  It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.

510(k) Number

K032734 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Duoderm Hydroactive Gel

  Unclassified

  FDA 510(k) K973806 Active Cleared 29 Dec 1997

• Duoderm Hydroactive Gel Wound Dressing

  Unclassified

  FDA 510(k) K990368 Active Cleared 26 Mar 1999

• Duoderm Hydroactive Paste

  Unclassified

  FDA 510(k) K973807 Active Cleared 23 Dec 1997

• Duoderm Extra Thin Cgf Dressing

  Unclassified

  FDA 510(k) K973716 Active Cleared 17 Dec 1997

• Combiderm Acd

  Class I

  FDA 510(k) K954918 Active Cleared 26 Dec 1995

• Epiview

  Unclassified

  FDA 510(k) K940895 Active Cleared 22 Nov 1994

See all devices from Convatec, A Bristol-Myers Squibb Co. →