B. Braun Catheter Connectors Recalled for Leakage and Disconnection
B. Braun Medical is recalling 1,350 CNB400TU3KUE 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 risk of harm (leakage/disconnection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,350 units of the CNB400TU3KUE 18GX4 CONTI THY ULTRA 360 catheter connectors (Material Number 332170). These devices are used by physicians to provide a common access point to a catheter for the 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 connectors has been observed. The affected batch number is 61602050.
The products were distributed nationwide in the United States as well as in Australia, Canada, Guatemala, and Kuwait. Healthcare providers should stop using the affected devices and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 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
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 1,350
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: 61602050
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.
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