Recall Z-0654-2026— B Braun Medical Inc
Class II · Ongoing
Class II FDA medical device recall by B Braun Medical Inc, initiated 2025-10-29. It names 2 FDA 510(k) clearances: K083723, K790062. Product: IV Administration 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. IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks; Catalog Number: 354210. 2. IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN.; Catalog Number: 490389.. 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
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IV Administration 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. IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks; Catalog Number: 354210. 2. IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN.; Catalog Number: 490389.
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.