B Braun Medical Inc: Device Recall

Recall Details

Recall Number

Z-0618-2026

Classification

Class II

Product Type

Device

Recalling Firm

B Braun Medical Inc

Status

Ongoing

Date Initiated

10/29/2025

Location

Bethlehem, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

33,528 units

Reason for Recall

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

Product Description

Blood Administration 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. Y-TYPE BLOOD SET, 3 CARSITE LADS, 146 IN; Catalog Number: 490530.

Distribution Pattern

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

Other Recalls by B Braun Medical Inc

• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

View all recalls by B Braun Medical Inc →