The Recall Desk
HighFDA (Devices)·Z-3363-2018·Announced 2018-10-10

B. Braun Medical Recalls CE17TK Epidural Catheter Connectors

B. Braun Medical is recalling 2,790 CE17TK epidural catheter connectors because they 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 is classified as FDA Class II, and the hazard involves a risk of harm (leakage/disconnection of medical devices) where specific injury reports are not detailed in the source text.

Plain-English summary

B. Braun Medical, Inc. is recalling 2,790 units of the CE17TK CONT EPIDURALTUOHY, Material Number 332221. This connection device is used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids. The affected units are identified by Batch 61597460.

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. This defect poses a risk of improper delivery of anesthetic fluids.

The affected products were distributed nationwide in the United States, as well as in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and users should stop using the affected connectors and contact B. Braun Medical for instructions on return or replacement.

The recalled product

Product
CE17TK CONT EPIDURALTUOHY, Material Number 332221 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 ca
Affected units
2,790

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 (1)

  • Batch: 61597460

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.

See all 93 products in this recall →