B. Braun EC19C Catheter Connectors Recalled for Leakage and Disconnection
B. Braun Medical is recalling EC19C catheter connectors because they may not stay closed, leading to leakage or disconnection during use.
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 where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 2,500 units of EC19C 19G x 100cm Catheter Closed (Material Number 333511). These connection devices are used by physicians to provide a common access point 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 61594132, 61604230, and 61618346.
The product was 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 instructions on return or replacement.
The recalled product
- Product
- EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 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 wit
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 2,500
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: 61594132
- 61604230
- 61618346
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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