B. Braun Medical Recalls CE18TB Epidural Trays Due to Leakage
B. Braun Medical is recalling CE18TB epidural trays because the catheter connectors may not stay closed, causing leakage or disconnection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect (leakage/disconnection) that poses a significant risk of harm to patients, meeting the criteria for a Severe rating.
Plain-English summary
B. Braun Medical, Inc. is recalling the CE18TB CONT EPIDURAL TRAY, Material Number 332222. 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 covers 57,820 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. The affected units are identified by specific batch numbers, including 61601679, 61600958, and others listed in the agency record.
This is an FDA Class II recall. Healthcare providers and facilities should stop using the affected devices and contact B. Braun Medical for instructions on how to return or dispose of them.
The recalled product
- Product
- CE18TB CONT EPIDURAL TRAY, Material Number 332222 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
- 57,820
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 (16)
- Batch: 61601679
- 61600958
- 61603831
- 61603833
- 61607929
- 61607931
- 61607930
- 61607933
- 61607937
- 61607938
- 61607939
- 61607934
- 61607941
- 61607940
- 61607935
- 61607932
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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