The Recall Desk
HighFDA (Devices)·Z-3335-2018·Announced 2018-10-10

B. Braun Medical Recalls CE18TKST Epidural Catheter Connectors

B. Braun Medical is recalling CE18TKST 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 defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any 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 CE18TKST CONT EPID W/SOFT TIP catheter connectors, Material Number 332081. These devices are used by physicians to provide a common access point to a catheter for the delivery of anesthetics and fluids. The recall involves 30,530 units distributed nationwide in the US and in Australia, Canada, Guatemala, and Kuwait.

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 could compromise the integrity of the anesthetic or fluid administration system.

Healthcare providers should stop using the affected connectors and contact B. Braun Medical for further instructions. The affected batch numbers are 61596061, 61600750, 61607496, 61610395, 61616566, 61606145, 61614140, 61618407, and 61620795.

The recalled product

Product
CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 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 th
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Catheter Connectors
Hazard
Affected units
30,530

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 (9)

  • Batch: 61596061
  • 61600750
  • 61607496
  • 61610395
  • 61616566
  • 61606145
  • 61614140
  • 61618407
  • 61620795

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

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Same hazard · leakage

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