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BfArM lists urgent field safety notice for Sterisets Steriflush water syringes

🇩🇪 BfArM field safety notices · Thu 22 Oct 2026

German regulator BfArM has published a manufacturer field safety notice covering Steriflush pre-filled water syringes, but the listing itself gives no details of the defect or affected lots.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 22 October 2026 concerning Steriflush syringes with water, made by Sterisets Manufacturing S.A. The entry is filed under reference 48816/26.

BfArM classifies the item in the product group Injections / Infusions / Transfusions / Dialysis, under infusion technology. The listing itself is brief and directs readers to the manufacturer's Advisory Notice, attached as a 201KB PDF, for further information and details on the device.

The public description does not state what the problem is, which lots or devices are affected, or what actions users are asked to take. Those points are not covered in the text available on the BfArM page, so they cannot be confirmed here.

As general context, a field safety notice is the communication a manufacturer sends to customers or users when it takes a field safety corrective action for a medical device. Regulators such as BfArM publish these notices so that affected parties can find them.

What it means for your team

  • Download and read the manufacturer's Advisory Notice attached to BfArM reference 48816/26, as the BfArM page does not describe the defect, lots or required actions.
  • Quality and supply-chain teams should check whether Steriflush water syringes from Sterisets Manufacturing S.A. are held in stock or used at their sites.
  • Any corrective actions, such as quarantine, return or user communication, should be taken only on the basis of the instructions in the manufacturer's notice.

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.

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