Z-1021-2025Class II

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to...

Name: Z-1021-2025 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to...
Creator: B. Braun Medical, Inc.
Published: 2024-12-04
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-12-04 / Open, Classified / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain... on 2024-12-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1021-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-04
Posted: 2025-01-24
Recalling firm: B Braun Medical Inc
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
Product code: OFT Spinal Epidural Anesthesia Kit
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: B Braun issued Urgent Medical Device Correction Notification letter on 12/04/24 via USPS Certified Mail. Letter states reason for recall, health risk and action to take: 1. Review the Medical Device Correction Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons are informed about this voluntary correction. If you have further distributed the affected product, please forward this notice to your consignees. The correction is to be extended to the hospital/healthcare facility level. 2. Post this notification where the affected products are stored. Additional catheter connectors are being supplied to you and should be stored where the affected inventory is utilized. In the event that an incorrect catheter connector is identified, please utilize these additional devices to facilitate replacement. 3. Returned the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or email to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-844-903-6417.
Quantity in commerce: 1090 units
Distribution: US Nationwide distribution in the states of MO, OK.
Product codes and lots: UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1021-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1021-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-24

Product code OFT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)