Lohmann and Rauscher International GmbH and Co. KG, 2022-20, Vliwaktiv Absorbent Activated Charcoal Dressing

Today, we have to inform you about the precautionary product recall of Vliwaktiv® Ab-sorbent activated charcoal dressing due to a possible insterility caused by a leaking seal seam of the primary packaging.

The products and batches affected by this defect were immediately quarantined in our warehouse.

During internal quality checks, the potential leakage of the seal seam was discovered. The product could be unsterile due to the potential leakage of the seal seam of the  pri-mary packaging. This could lead to inflammations and/or infections, e.g. when the prod-uct is used in wounds. So far, we have not received any evidence/complaints from the market about inflammations or infections.

Please return the products you have in stock using the enclosed form. The products will, of course, be exchanged free of charge or credited on request.

Please ensure in your organisation that all users of the products listed below and other persons to be informed are aware of this Urgent Field Safety Notice and return the en-closed confirmation to us completed. 

If you have passed on the products to third parties, please forward a copy of this infor-mation to them.

We thank you in advance for your cooperation and apologize for any inconvenience.

Fabrikant: Lohmann & Rauscher International GmbH & Co. KG
Product: Vliwaktiv® Absorbent Activated Charcoal Dressing
Datum FSN: (documentdatum) 22-11-2022

Waarschuwing van de fabrikant

Dit bericht is een waarschuwing van de fabrikant. Na het op de markt brengen van een medisch hulpmiddel is de fabrikant verplicht het hulpmiddel te volgen en waar nodig te verbeteren. Wanneer sprake is van een risico voor de gebruiker moet de fabrikant actie ondernemen. De fabrikant informeert gebruikers en de inspectie over deze actie met een waarschuwing (Field Safety Notice). Zie ook waarschuwingen medische hulpmiddelen. Dit hoort bij het toezicht op medische technologie.