Z-2627-2023Class II

Perifix / Epidural anesthesia set, medicated

Name: Z-2627-2023 Perifix / Epidural anesthesia set, medicated
Creator: B. Braun Medical, Inc.
Published: 2023-07-31
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2023-07-31 / Open, Classified / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Perifix / Epidural anesthesia set, medicated on 2023-07-31. FDA classified it as Class II and gives the reason as "Product may be mislabeled with an incorrect lid stock label". 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-2627-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-31
Posted: 2023-09-21
Recalling firm: B Braun Medical Inc
Product: Perifix / Epidural anesthesia set, medicated
Product code: OGE Epidural Anesthesia Kit
Reason for recall: Product may be mislabeled with an incorrect lid stock label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "URGENT MEDICAL DEVICE RECALL" letter dated 8/14/23 was issued to affected customers on 08/14/2023. The letter described the product, problem and actions to be taken. The Customers are instructed to review inventory, cease use and quarantine impacted product and complete and return the Product Recall Acknowledgement Form back to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610)849-1197 or email to [email protected]. B. Braun Medical will facilitate return of impacted product. If you have any questions, contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
Quantity in commerce: 3440 units
Distribution: US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
Product codes and lots: UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2627-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2627-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-21

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)