Recall Z-0635-2026 ยท FPA Set, Administration, Intravascular
B Braun Medical Inc
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. EXT SET ULTRAPORT STOPCOCK, 37IN.; Catalog Number: 490234.
| Date | Nov 26, 2025 (initiated Oct 29, 2025) |
| Status | Open, Classified |
| Reason | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Root cause | Process control |
| Action | B Braun notified consignees on about 10/29/2025 via letter. Consignees were instructed to follow "Interim Measures for Users" as outlined in the letter for secondary infusions via gravity sets and if using secondary infusions with infusion pumps. Consignees were also instructed to inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where IV administration sets and pump administration sets may be stored until further notice. B. Braun will provide additional notification when users may resume their normal secondary administrati |
| Quantity | 27,480 units |
| Distribution | Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. |
| FDA record | Open on fda.gov |