FDA-Device2025-12-03Class IIPROCESSING DEFECT
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 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Affected count
89,552 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
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 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML 120 IN.; Catalog Number: 490428.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0648-2026More B. Braun recalls
- FDA-Device2026-09-09B Braun Discofix Four Way Stopcock recalled for incorrect expiration date
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