Recalls / —

—#202878

Product

Perifix / Epidural anesthesia set, medicated

FDA product code

OGE — Epidural Anesthesia Kit

Device class

Class 2

Medical specialty

Anesthesiology

Affected lot / code info

UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025

Why it was recalled

Product may be mislabeled with an incorrect lid stock label.

Root cause (FDA determination)

Process control

Action the firm took

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 PA_QualityAssurance.BBMUS_Service@bbraunusa.com. 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.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA

Timeline

Recall initiated

2023-07-31

Posted by FDA

2023-09-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.