The Recall Desk
HighFDA (Devices)·Z-3376-2018·Announced 2018-10-10

B. Braun Recalls Epidural Catheter Connectors Due to Leakage and Disconnection

B. Braun Medical is recalling 4,150 epidural catheter connectors because they may not stay closed, causing 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 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 4,150 units of the CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262. This product is a connection device 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 batches are 61590151, 61599650, 61606619, 61613555, and 61619293.

The product was distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare providers should stop using the affected devices and contact B. Braun Medical for instructions on returning or replacing the product.

The recalled product

Product
CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 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 t
Affected units
4,150

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: 61590151
  • 61599650
  • 61606619
  • 61613555
  • 61619293

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 →