B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage Risk
B. Braun Medical is recalling 3,050 epidural 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 defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 3,050 units of Epidural Catheter Connectors (Material Number 333541). The affected products are identified by batch numbers 61605308 and 61608018. These devices are connection points used by physicians to administer anesthetics and fluids through a catheter.
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, as well as in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and providers who have received these specific batch numbers should stop using the devices and contact B. Braun Medical for instructions on return or replacement.
The recalled product
- Product
- EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 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 w
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 3,050
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 (2)
- Batch: 61605308
- 61608018
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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