B. Braun Medical, Inc.: Device Recall

Recall Details

Recall Number

Z-1021-2025

Classification

Class II

Product Type

Device

Recalling Firm

B. Braun Medical, Inc.

Status

Ongoing

Date Initiated

12/04/2024

Location

Allentown, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1090 units

Reason for Recall

Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.

Product Description

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159

Distribution Pattern

US Nationwide distribution in the states of MO, OK.

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. →