B. Braun Medical Recalls CE17TFC Continuous Epidural Sets
B. Braun Medical is recalling CE17TFC Continuous Epidural Sets 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 without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling the CE17TFC Continuous Epidural Set with 17G Tuohy, Material Number 332238. 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 were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. The specific batch numbers involved are 61590460, 61594135, 61598572, 61601772, 61605134, 61610126, 61613471, 61615656, 61618348, and 61621766. Healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 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 conjuncti
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 20,280
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 (10)
- Batch: 61590460
- 61594135
- 61598572
- 61601772
- 61605134
- 61610126
- 61613471
- 61615656
- 61618348
- 61621766
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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