Urgent Field Safety Notice For Arrow Haemodialysis Kits And Sets: 16f Dual-valved Splittable Sheath Introducer By Arrow International Inc. Us
Recall Summary Arrow International Inc. is recalling 16F Dual-Valved Splittable Sheath Introducers used in haemodialysis kits and sets distributed in Germany and the EU due to an unspecified safety risk. This is a Class I recall, the most serious classification. The recall affects medical facilities and patients in Germany and other European Union countries using these specific dialysis introducers.
- Recalling firm
- Urgent Field Safety Notice for Arrow Haemodialysis Kits and Sets: 16F Dual-Valved Splittable Sheath Introducer by Arrow
- Product
- s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Arrow Haemodialysis Kits and Sets: 16F Dual-Valved Splittable Sheath Introducer by Arrow International Inc
- Reason
- assessment Field corrective actions Urgent Field Safety Notice for Arrow Haemodialysis Kits and Sets: 16F Dual-Valved Splittable Sheath Introducer by Arrow International Inc
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-04-14
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/53880e0a-2b6d-4ce0-8306-bbf7d9449dd9