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 ADMIN SET HF STOPCOCK,107 IN.; Catalog Number: 490241. 2. IV ADMIN SET W/15 DROPS/ML, 116 IN.; Catalog Number: 490298. 3. IV ADMIN SET,15 DROP,4 CARESITE, 119 IN.; Catalog Number: 490360.
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
66,792 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 ADMIN SET HF STOPCOCK,107 IN.; Catalog Number: 490241. 2. IV ADMIN SET W/15 DROPS/ML, 116 IN.; Catalog Number: 490298. 3. IV ADMIN SET,15 DROP,4 CARESITE, 119 IN.; Catalog Number: 490360.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0652-2026More B. Braun recalls
- FDA-Device2026-09-09B Braun Discofix Four Way Stopcock recalled for incorrect expiration date
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