The Recall Desk
HighFDA (Devices)·Z-3365-2018·Announced 2018-10-10

B. Braun Medical Recalls CE18HB Epidural Catheter Connectors

B. Braun Medical is recalling CE18HB epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

What this means for you

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 with a functional defect (leakage/disconnection) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

B. Braun Medical, Inc. is recalling CE18HB CONT EPIDURAL HUSTEAD catheter connectors, Material Number 332223. These connection devices are used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids.

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. The affected units were distributed nationwide in the US and in Australia, Canada, Guatemala, and Kuwait.

Healthcare providers should stop using the affected connectors and contact B. Braun Medical for further instructions. The recall involves specific batch numbers, including 61600775, 61607953, and 61607952.

The recalled product

Product
CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 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 the
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Catheter Connectors
Hazard
Affected units
24,850

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 (13)

  • Batch: 61600775
  • 61607953
  • 61607952
  • 61607954
  • 61607958
  • 61602694
  • 61607955
  • 61607956
  • 61607957
  • 61607960
  • 61612147
  • 61611469
  • 61610329

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 →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · leakage

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