B. Braun Medical, Inc.: Device Recall

Recall Details

Recall Number

Z-2396-2024

Classification

Class II

Product Type

Device

Recalling Firm

B. Braun Medical, Inc.

Status

Ongoing

Date Initiated

06/17/2024

Location

Allentown, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

13464 units

Reason for Recall

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

Product Description

Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

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. →