WhichRecall
Class IIReported 2025-12-03

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.

Recalled by B Braun Medical Inc

Reason for Recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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Recall Number
Z-0603-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-29
Reported
2025-12-03
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Code Info
1. Catalog Number: V1443; Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447; Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448; Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. 4. Catalog Number: V1484; Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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