The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2002-2023·Announced 2023-07-05

Perifix Epidural Anesthesia Kits Recalled for Incorrect Filter Straw

B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a component assembly defect in epidural anesthesia kits. No injuries or illnesses have been reported. The score reflects a risk-of-harm product where the defect has not resulted in reported adverse events, placing it in the High category.

Plain-English summary

B. Braun Medical, Inc. recalled Perifix epidural anesthesia kits (Model Nos. 332217, 332097, 332220, 332078) due to assembly errors in which kits were assembled with the incorrect filter straw.

The recall affects 16,070 units distributed nationwide across the United States. Affected lot numbers include 0061850767, 0061855339, 00618553400061858554, and 0061837264.

Healthcare providers and facilities that have received affected kits should contact B. Braun Medical, Inc. for instructions on return or replacement. Patients should consult with their healthcare provider if they have concerns about any procedures performed with affected kits.

The recalled product

Product
Perifix¿ / Epidural anesthesia kit (10 count carton)
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Epidural Anesthesia
Hazard
Affected units
16,070

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 (12)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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