Home / Recalls / B Braun Medical Inc / Z-0621-2026

Z-0621-2026 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
12,320 units

Product Description

Burette 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. BURETTE SET, 4 CARESITE LADS, STPCK 125"; Catalog Number: 490252.

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

Catalog Number: 490252; Primary UDI-DI: 04046955545636; Unit of Dose UDI-DI: 04046955545629.

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  • Z-1481-2026 Class II — Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/ (February 2, 2026)
  • Z-1482-2026 Class II — Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catal (February 2, 2026)
  • Z-0671-2026 Class II — IV Administration Set utilized in gravity IV administration sets and pump admini (October 29, 2025)
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  • Z-0680-2026 Class II — IV Administration Set utilized in gravity IV administration sets and pump admini (October 29, 2025)
  • Z-0610-2026 Class II — Anesthesia IV Set utilized in gravity IV administration sets and pump administra (October 29, 2025)
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