B. Braun Medical Recalls CE17TO Epidural Catheter Connectors
B. Braun Medical is recalling CE17TO epidural catheter connectors because they may not stay closed, leading to 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 3/5 (High).
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 mechanical 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 CE17TO CONT EPIDURAL SET LF (Material Number 332204) catheter connectors. These devices are used by physicians to provide a common access point to a catheter for the delivery of anesthetics and 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 connectors has been observed.
The affected units were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. The specific batch numbers involved are 61609098, 61620830, and 61592464. A total of 612 units are subject to this recall.
The recalled product
- Product
- CE17TO CONT EPIDURAL SET LF, Material Number 332204 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
- 612
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: 61609098
- 61620830
- 61592464
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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