Z-1149-2024Class II

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5...

Name: Z-1149-2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5...
Creator: B. Braun Medical, Inc.
Published: 2024-01-22
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-01-22 / Open, Classified / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of... on 2024-01-22. FDA classified it as Class II and gives the reason as "Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit". 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-1149-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-22
Posted: 2024-02-16
Recalling firm: B Braun Medical Inc
Product: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. Product Code: 332079
Product code: OGE Epidural Anesthesia Kit
Reason for recall: Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: B.Braun issued Urgent Medical Device Recall letter on Monday, January 22, 2024. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification and ensure that all users of the product in your organization, and other concerned personnel are informed about this recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the user level. 2. Determine your current inventory of the affected batches within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Record the total number of individual impacted units on the Recall Acknowledgement Form. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Recall Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Recall Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.
Quantity in commerce: 3,480 units
Distribution: US Nationwide
Product codes and lots: UDI: 04046964177224 Lot Number: 0061855319 Exp. Date: 30.APR.2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1149-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1150-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code OGE

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)