The Recall Desk
HighFDA (Devices)·Z-3367-2018·Announced 2018-10-10

B. Braun Medical Recalls Epidural Anesthesia Kits Due to Leakage

B. Braun Medical is recalling CE17TKCD epidural anesthesia kits because the catheter connectors 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 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 1,370 units of the CE17TKCD CONT EPIDURAL ANESTHESIA KIT (Material Number 332229). The 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 covers batch 61600741.

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 delivery of anesthetic fluids.

The affected products were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare providers and patients should stop using the affected kits and contact B. Braun Medical for instructions on replacement or return.

The recalled product

Product
CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 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
Affected units
1,370

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 (1)

  • Batch: 61600741

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 →