The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2627-2023·Announced 2023-09-27

Epidural Anesthesia Sets Recalled Due to Incorrect Lid Stock Label

B. Braun Medical is recalling approximately 3,440 Perifix® epidural anesthesia sets due to incorrect labeling of the lid stock. The mislabeled products were distributed to multiple U.S. states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a labeling error on a Class II medical device with no reported illnesses, injuries, or hospitalizations. The hazard is limited to mislabeling of the lid stock, consistent with minor labeling errors in the recall classification guidelines.

Plain-English summary

B. Braun Medical, Inc. is recalling Perifix® epidural anesthesia sets due to a mislabeling issue affecting the lid stock label. Approximately 3,440 units are being recalled.

The recalled products may be mislabeled with an incorrect lid stock label. The affected units are lot number 0061863524 with an expiration date of April 30, 2025.

The recalled sets were distributed across the United States to the following states: Arkansas, Arizona, California, Florida, Georgia, Illinois, Massachusetts, Missouri, North Carolina, New Jersey, Pennsylvania, Texas, and Washington.

Healthcare providers who have the recalled products should contact B. Braun Medical, Inc. or the FDA for information about the recall and disposition instructions.

The recalled product

Product
Perifix¿ / Epidural anesthesia set, medicated
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Epidural anesthesia
Hazard
Affected units
3,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 13 states:

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