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Open, Classified

Perifix / Epidural anesthesia set, medicated

FDA Recall Z-2627-2023 · Posted 2023-09-21

Recalling FirmB. Braun Medical, Inc.
Recall StatusOpen, Classified
Product CodeOGE
Date Initiated2023-07-31
Product Quantity3440 units

Reason for Recall

Product may be mislabeled with an incorrect lid stock label.

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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