Recall Z-0638-2026— B Braun Medical Inc
Class II · Ongoing
Class II FDA medical device recall by B Braun Medical Inc, initiated 2025-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Caresite Extension Set_Export; Catalog Number: 470183.. Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion)..
- Recalling firm
- B Braun Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-29
- Firm location
- Bethlehem, PA, United States
Product description
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Caresite Extension Set_Export; Catalog Number: 470183.
Reason for recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Data sourced from openFDA. This site is unofficial and independent of the FDA.