FDA Medical devices recall ·
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration… recall
- Recall number
- Z-1021-2025
- Date
- (initiated December 4, 2024)
- Company / brand
- B Braun Medical Inc
901 Marcon Blvd, Allentown, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1090 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572
Distribution
US Nationwide distribution in the states of MO, OK.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1021-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.