BEUDAMED
    FDA Enforcement Class II Ongoing

    Caresite 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 with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

    Recall: Z-0624-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0624-2026
    Event ID
    97816
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2025
    Initiation Date
    October 29, 2025
    Classification Date
    November 26, 2025
    Address
    824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States

    Description

    Caresite 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 with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

    Reason

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

    Code Info

    1. Catalog Number: 354204; Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068. 2. Catalog Number: 354205; Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082. 3. Catalog Number: 354206; Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105.

    Distribution

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

    Quantity

    12,225,913 units