CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report

Perifix¿ / Epidural anesthesia set, medicated recalled

B. Braun Medical is recalling Perifix¿ / Epidural anesthesia set, medicated, distributed in 13 states. The recall was initiated on 31 Jul 2023 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled3440 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2627-2023
FDA event ID: 92913
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jul 2023
FDA classified: 21 Sep 2023
Reported: 27 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

31 Jul 2023	Recall initiated by company
21 Sep 2023	Classified by FDA	+52 days
27 Sep 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product may be mislabeled with an incorrect lid stock label.

Product as listed by the FDA

Perifix¿ / Epidural anesthesia set, medicated

Where it was distributed

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

Arkansas Arizona California Florida Georgia Illinois Massachusetts Missouri North Carolina New Jersey Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Product may be mislabeled with an incorrect lid stock label.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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