FDA-Device2025-12-03Class II
Caresite 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. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207.
B Braun Medical Inc
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Sold states
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Affected count
381,850 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
Caresite 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. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0626-2026Don't want to check this manually?
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