Agency classClass IIOur severity:High FDA (Devices)·Z-3372-2018·Announced 2018-10-10

B. Braun Medical Recalls CE17TOD Epidural Tray Connectors

B. Braun Medical is recalling CE17TOD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.

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: The recall involves a medical device defect that can lead to leakage or disconnection during anesthetic administration. This is classified as High because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II.

Plain-English summary

B. Braun Medical, Inc. is recalling 1,980 units of the CE17TOD CONT EPIDURAL TRAY LF (Material Number 332235). This connection device is used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids. The affected units are identified by batch numbers 61604903 and 61618120.

The recall was initiated because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the connectors has been observed. This defect poses a risk of unintended fluid loss or interruption of anesthetic delivery.

The affected products were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and users should stop using the affected connectors and contact B. Braun Medical for instructions on returning or replacing the devices.

The recalled product

Product: CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with…
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Anesthesia / Infusion
Hazard: leakage
disconnection
Affected units: 1,980

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 (2)

Batch: 61604903
61618120

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 93 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 93 products in this recall →

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Same hazard · leakage