B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage
B. Braun Medical is recalling CE17TKCDLS epidural trays because the catheter connectors 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 (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 8,210 units of the CE17TKCDLS CONT EPIDURAL TRAY (Material Number 332212). This connection device is used by physicians to provide a single access point to a catheter 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 units are identified by batch numbers 61589440, 61595168, 61602897, 61607727, 61612246, 61616728, and 61620762.
The affected products were distributed nationwide in the United States and 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
- CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 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 th
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 8,210
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 (7)
- Batch: 61589440
- 61595168
- 61602897
- 61607727
- 61612246
- 61616728
- 61620762
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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