Agency classClass IIOur severity:High FDA (Devices)·Z-1149-2024·Announced 2024-02-28

PERIFIX epidural kits recalled for incompatible filter straw connectors

B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.

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 FDA Class II medical device recall involves a component compatibility issue in an epidural administration kit. While no injuries have been reported, the defect prevents proper assembly and use of a critical pain management device, representing a risk-of-harm scenario in a serious medical procedure context.

Plain-English summary

B. Braun Medical, Inc. is recalling approximately 3,480 PERIFIX epidural kits distributed nationwide. These kits are intended for the administration of analgesic or anesthetic agents to the epidural space for pain management.

The kits are being recalled because the filter straws contain Neuraxial connectors instead of the specified Standard Luer Connections. This connector mismatch prevents the filter straws from properly interfacing with other components of the kit, rendering the kit unusable as designed.

Healthcare facilities and providers who have received affected kits should discontinue use of lot 0061855319 (expiration date April 30, 2024) and contact B. Braun Medical, Inc. for instructions on return or replacement. The UDI for the affected product is 04046964177224.

No injuries or adverse events have been reported in association with this recall. However, given that the kits cannot be properly assembled, they should not be used for patient care.

The recalled product

Product: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management…
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Epidural Administration Kit
Hazard: component-mismatch
device-incompatibility
Affected units: 3,480

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 (1)

UDI: 04046964177224 Lot Number: 0061855319 Exp. Date: 30.APR.2024

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 →

Same manufacturer · B. Braun Medical, Inc.

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