🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 4, 2024 B. Braun Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
B. Braun Medical, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1021-2025

Related Recalls

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 W/ 170 ?M FILTER 120 IN; Catalog Number: 490355.

B Braun Medical

Class I - Dangerous

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

Oct 29, 2025 Infusion Pumps View Details →

IV 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. IV ADMIN SET W/15 DROPS/ML 126 IN; Catalog Number: 490283.

B Braun Medical

Class I - Dangerous

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

Oct 29, 2025 Infusion Pumps View Details →

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 124 IN.; Catalog Number: 490196.

B Braun Medical

Class I - Dangerous

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

Oct 29, 2025 Infusion Pumps View Details →