B. Braun Recalls Pediatric Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling 1,380 pediatric epidural catheter connectors because they may not stay closed, causing 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 or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,380 units of the CEP18TKO CONT. EPIDURAL PEDIATRIC KIT (Material Number 332290). 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 are from batches 61599642 and 61615741.
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 and in Australia, Canada, Guatemala, and Kuwait. Healthcare providers and patients should stop using the affected connectors and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 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
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 1,380
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: 61599642
- 61615741
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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