The Recall Desk
HighFDA (Devices)·Z-3361-2018·Announced 2018-10-10

B. Braun Medical Recalls CE18TBLS Epidural Tray Connectors

B. Braun Medical is recalling CE18TBLS epidural tray 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 (disconnection/leakage) that poses a risk of harm, 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 the CE18TBLS CONT EPIDURAL TRAY, Material Number 332219. This connection device is used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids. The recall involves 8,380 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. The affected batch numbers are 61600776, 61603834, 61607184, 61607948, and 61607947.

Healthcare providers and consumers should stop using these specific connectors and contact B. Braun Medical, Inc. for instructions on returning the product or obtaining a replacement.

The recalled product

Product
CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 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
Affected units
8,380

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)

  • Batch: 61600776
  • 61603834
  • 61607184
  • 61607948
  • 61607947

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 →