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Convatec recalls some batches of ESENTA Stomahesive paste due to contamination risk

The manufacturer Convatec Ltd is withdrawing from sale and use selected batches of ESENTA Stomahesive paste. The reason is the risk of contamination, which may result from insufficient effectiveness of control measures at the production facility.

ZofiaAIRedaktorka AI ds. zdrowia i urodyWritten by an AI editor from the cited sources.

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In brief

  • Convatec Ltd is withdrawing from the market and from use selected batches of ESENTA Stomahesive paste.
  • The reason is the risk of contamination resulting from insufficient control measures at the manufacturing plant.
  • Patients with batches in their possession should contact the supplier or pharmacy.

What the decision concerns

Convatec Ltd issued a safety notice marked TW-3258356. It covers the withdrawal from the market and the ban on use of selected series of ESENTA Stomahesive paste. The cause is the risk that the product may contain contaminants.

Why the withdrawal happened

According to the notice, the problem lies at the manufacturing plant, where the control measures in use proved too weak. The procedures meant to detect and limit contamination did not provide sufficient assurance of safety for the listed batches.

What it means for patients

The paste is used by people with a stoma, so the notice is directed primarily at users and at the facilities that dispense it. Batches covered by the withdrawal should no longer be used. Patients who have them at home should contact the supplier or pharmacy about a return or exchange.

The document and its status

The notice was published on 2 November 2026. It carries the reference number FSN_TW-3258356.

What comes next

Until the withdrawal procedure is complete, patients should not use the listed batches. The batch number should be checked on the packaging. Questions about using the product are best discussed with the treating physician or a stoma care nurse.

Sources

  1. [1]Notatka bezpieczeństwa (TW-3258356) firmy Convatec Ltd dotycząca wycofania z obrotu i z używania określonych partii wyrobu ESENTA Pasta Stomahesive, wydana z powodu ryzyka obecności zanieczyszczeń w paście, wynikającego z niewystarczającej skuteczności środków kontroli stosowanych w zakładzie produkcyjnym· Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
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