FDA-Device2025-12-03Class IIPROCESSING DEFECT
ADDitIV 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 numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Who it affects
All ages (0 months and older)
Illnesses reported
None reported
Sold states
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Affected count
43,900 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
ADDitIV 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 numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1484.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0603-2026Don't want to check this manually?
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