The Recall Desk
HighFDA (Devices)·Z-3342-2018·Announced 2018-10-10

B. Braun Medical Recalls 17 GA Epidural Catheter Connectors

B. Braun Medical is recalling specific epidural catheter connectors that may not stay closed, leading to potential 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 where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling the CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096. This product is a connection device used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids. The recall involves 3,130 units.

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 batches are 61587790 and 61604448.

The product was distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and consumers should stop using the affected devices and contact B. Braun Medical for further instructions.

The recalled product

Product
CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 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 w
Affected units
3,130

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 (2)

  • Batch: 61587790
  • 61604448

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 →