CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report

Perifix¿ / Epidural anesthesia kit carton) recalled by B. Braun Medical

B. Braun Medical is recalling Perifix¿ / Epidural anesthesia kit carton), distributed nationwide in the US. The recall was initiated on 5 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 332217, 332097, 332220, 332078; GTIN: 04046964178283, 04046964177361, 04046964177361, 04046964178320, 04046964177200; Lot No. 0061850767, 0061855339, 00618553400061858554, 0061837264.

Quantity recalled16,070 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-2002-2023
FDA event ID: 92523
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Jun 2023
FDA classified: 23 Jun 2023
Reported: 5 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Jun 2023	Recall initiated by company
23 Jun 2023	Classified by FDA	+18 days
5 Jul 2023	Published in enforcement report	+12 days

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

Reason for recall

Kits were assembled with the incorrect Filter Straw.

Product as listed by the FDA

Perifix¿ / Epidural anesthesia kit (10 count carton)

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Kits were assembled with the incorrect Filter Straw.

Which lots are affected?

Model No. 332217, 332097, 332220, 332078; GTIN: 04046964178283, 04046964177361, 04046964177361, 04046964178320, 04046964177200; Lot No. 0061850767, 0061855339, 00618553400061858554, 0061837264.

Where was it sold?

US Nationwide distribution.

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.

Other products in this recall event

1 other product · FDA event 92523

This product is part of a recall event; the main page for the event is Design Options¿ / Epidural anesthesia kit carton) recalled.

Reported	Class	Recall	Company	Reason	Where
5 Jul 2023	CLASS II	Design Options¿ / Epidural anesthesia kit carton) recalled	B. Braun Medical	Other	Nationwide

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