B. Braun Medical Recalls CE17TKFCPS Epidural Full Tray Connectors
B. Braun Medical is recalling CE17TKFCPS Epidural Full Tray 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 is classified as FDA Class II. The hazard involves a risk of harm (leakage/disconnection) in a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
B. Braun Medical, Inc. is recalling the CE17TKFCPS Epidural Full Tray, Material Number 332078. 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 were distributed worldwide, including the United States (nationwide), Australia, Canada, Guatemala, and Kuwait. The specific batch numbers involved are 61585927, 61588415, 61595498, 61600756, 61605153, 61609150, 61614790, 61617961, and 61620772. The total quantity of units involved is 25,020. Healthcare providers should stop using these devices and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 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…
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 25,020
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 (9)
- Batch: 61585927
- 61588415
- 61595498
- 61600756
- 61605153
- 61609150
- 61614790
- 61617961
- 61620772
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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