Home / Recalls / B Braun Medical Inc / Z-0707-2026

Z-0707-2026 Class II Ongoing

Recalled by B Braun Medical Inc — Bethlehem, PA

Recall Details

Product Type
Devices
Report Date
December 3, 2025
Initiation Date
October 29, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,072 untis

Product Description

Outlook 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. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213.

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Code Information

1. Catalog Number: 354213; Primary UDI-DI: 04046964182211; Unit of Dose UDI-DI: 04046964182204; Expiration Date: Earliest Exp of Comp or 36mths.

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  • Z-1482-2026 Class II — Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catal (February 2, 2026)
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  • Z-0610-2026 Class II — Anesthesia IV Set utilized in gravity IV administration sets and pump administra (October 29, 2025)
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