B. Braun Medical Recalls CE18TKCD Epidural Catheter Connectors
B. Braun Medical is recalling CE18TKCD 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 with a functional defect that could lead to leakage or disconnection during anesthesia administration. While no specific injuries are reported in the text, the risk of harm from improper drug delivery or loss of access justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the CE18TKCD CONT EPIDURAL TRAY, Material Number 332211. This 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 recall involves 10,470 units distributed in the United States and in Australia, Canada, Guatemala, and Kuwait. The affected batches are 61594893, 61596328, and 61614703.
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.
Healthcare providers and facilities should stop using the affected devices and contact B. Braun Medical for instructions on return or replacement. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 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 with the
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 10,470
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: 61594893
- 61596328
- 61614703
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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