B. Braun Medical Recalls CE18HKPS Continuous Epidural Trays
B. Braun Medical is recalling CE18HKPS Continuous 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, 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 2,040 units of the CE18HKPS Continuous Epidural Tray, Material Number 332231. This connection device is used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for the delivery of anesthetics. The connector is used in conjunction with the catheter for the continuous administration of anesthetic fluids.
The recall is being issued because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. The affected units are identified by the following batch numbers: 61596319, 61599764, 61603312, 61612410, 61616941, and 61622918.
The affected products were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare providers and facilities should stop using the affected devices and contact B. Braun Medical, Inc. for further instructions.
The recalled product
- Product
- CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 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 t
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 2,040
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 (6)
- Batch: 61596319
- 61599764
- 61603312
- 61612410
- 61616941
- 61622918
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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