The Recall Desk
HighFDA (Devices)·Z-3316-2018·Announced 2018-10-10

B. Braun Medical Recalls Contiplex Tuohy Ultra Catheter Connectors

B. Braun Medical is recalling 168 Contiplex Tuohy Ultra 2-in-1 connector sets because the 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 defect (leakage/disconnection) that poses a risk of harm during use, but the source text does not report any specific injuries, illnesses, or fatalities, 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 168 units of the Contiplex Tuohy Ultra 2-in-1 Connector PNB Set, Material Number 33167400. 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 affected units were distributed nationwide in the United States 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 poses a risk of fluid leakage or loss of connection during medical procedures.

Healthcare providers and patients should stop using the affected product immediately. B. Braun Medical is the recalling firm responsible for managing the recall. No specific instructions for consumers are provided in the source text beyond the identification of the defect and the recall action.

The recalled product

Product
CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 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 conjunct
Affected units
168

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: 61597400

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 →