The Recall Desk
HighFDA (Devices)·Z-3327-2018·Announced 2018-10-10

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

B. Braun Medical is recalling 430 units of CONT STIM BASIC KIT W/4 IN INSUL TUOHY 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 any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling 430 units of the CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758. This product is a connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for the delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic 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 catheter connectors has been observed. The affected batches are 61606946, 61613536, and 61619213.

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

The recalled product

Product
CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 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 conjunctio
Affected units
430

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 (3)

  • Batch: 61606946
  • 61613536
  • 61619213

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 →