Convatec recalls

Convatec appears in 54 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexib…
  FDA Device · Class II · 2014-03-26 · Convatec
  Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
• Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard cat…
  FDA Device · Class II · 2014-03-26 · Convatec
  Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
• ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid s…
  FDA Device · Class III · 2013-08-28 · Convatec
  Reason: 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 dup…
• ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of l…
  FDA Device · Class III · 2013-08-28 · Convatec
  Reason: 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 dup…