Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0114-2026·Announced 2025-10-15

Epidural basic trays recalled over catheter connector lid position defect

B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TBFC, because the lid of the catheter connector may be in the incorrect position.

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: Scored 2 because the record describes a component position defect without stating a hazard, clinical consequence or reported harm.

Plain-English summary

PERIFIX FX Continuous Epidural Anesthesia Trays with a PERIFIX 17 Ga. x 3-1/2 in. Tuohy epidural needle and a PERIFIX FX springwound 19 Ga. closed tip catheter, product code CE17TBFC, are being recalled because of the potential for the lid of the catheter connector to be in the incorrect position.

The affected product is REF 332077, carrying primary UDI-DI 4046964177187 and unit-of-use UDI-DI 4046964177170. The enforcement record lists the quantity as 0 units. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.

The enforcement record describes the connector lid position and does not state any injury or clinical consequence. Facilities should check affected lots and follow B. Braun's instructions.

The recalled product

Product: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
Manufacturer: B BRAUN MEDICAL INC
Category: Medical Device — Anesthesia tray
Hazard: component-defect
connector-position

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 (5)

REF: 332077
Product Code: CE17TBFC
UDI-DI (Primary): 4046964177187
UDI-DI (Unit of Use): 4046964177170
Lot Number: 0062022053. Expiration Date: 10/16/2024

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Same manufacturer · B BRAUN MEDICAL INC

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Same hazard · component defect