Quality & complianceOfficial

BfArM publishes ConvaTec urgent field safety notice for Stomahesive Paste stoma care product

🇩🇪 BfArM field safety notices · Fri 23 Oct 2026

Germany's BfArM has listed a ConvaTec field safety notice for US-sourced Stomahesive Paste, but the public entry does not describe the problem or the corrective actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from ConvaTec Inc covering Stomahesive Paste. The entry is dated 23 October 2026 and carries the reference 48328/26.

The product is identified as Stomahesive Paste in a 1 tube x 56.7 g presentation, marked as US. BfArM classes it under dressings and pads, specifically ointments and gels.

The public listing does not say why the notice was issued. It gives no information on the defect, affected lots or batches, risk to users, or the actions requested of customers. BfArM refers readers to the manufacturer's enclosed Advisory Notice for those details and for information on the device.

The notice is available as a 7 MB PDF download. BfArM states that the file does not meet accessibility standards.

What it means for your team

  • Obtain and read the full ConvaTec Advisory Notice from BfArM's download; the web listing alone gives no basis for assessing impact.
  • Distributors, hospitals and suppliers handling the US-sourced 56.7 g tube should check their stock and records against the lot details in the notice once reviewed.
  • Quality and vigilance teams should log reference 48328/26 and follow any response or acknowledgement steps set out by the manufacturer.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

More Quality & compliance All →