B. Braun Medical Recalls CE17TKPS Continuous Epidural Anesthesia Trays
B. Braun Medical is recalling CE17TKPS Continuous Epidural Anesthesia 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 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 CE17TKPS Continuous Epidural Anesthesia Trays, Material Number 332233. These connection devices are used by physicians to provide a single, common access point to a catheter for the delivery of anesthetics and fluids. The recall involves 2,400 units distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait.
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 that have received these trays should stop using the affected units and contact B. Braun Medical, Inc. for further instructions on the recall process.
The recalled product
- Product
- CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 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 conjunctio
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 2,400
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 (5)
- Batch: 61582595
- 61599648
- 61605283
- 61611124
- 61614787
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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