Home / Recalls / B Braun Medical Inc / Z-0625-2026

Z-0625-2026 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
2,871,707 units

Product 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 15 DROP W/2 CARESITE; Catalog Number: 354202. 2. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADM 15DROP W/2 CARESITE SLIDECLMP; Catalog Number: 354203.

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: 354202; Primary UDI-DI: 04046964182037; Unit of Dose UDI-DI: 04046964182020. 2. Catalog Number: 354203; Primary UDI-DI: 04046964182051; Unit of Dose UDI-DI: 04046964182044.

Other recalls by B Braun Medical Inc

  • Z-1483-2026 Class II — Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7 (February 2, 2026)
  • 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-0646-2026 Class II — IV Administration Set utilized in gravity IV administration sets and pump admini (October 29, 2025)
  • Z-0640-2026 Class II — Infusomat utilized in gravity IV administration sets and pump administration set (October 29, 2025)
  • Z-0703-2026 Class II — IV Administration Set utilized in gravity IV administration sets and pump admini (October 29, 2025)
  • Z-0621-2026 Class II — Burette Set utilized in gravity IV administration sets and pump administration s (October 29, 2025)
  • Z-0671-2026 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)
  • Z-0694-2026 Class II — IV Administration Set utilized in gravity IV administration sets and pump admini (October 29, 2025)