The Recall Desk
HighFDA (Devices)·Z-3343-2018·Announced 2018-10-10

B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

B. Braun Medical is recalling 93,140 epidural catheter connectors because they may not stay closed, causing 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 defect (leakage/disconnection) that poses a risk of harm to patients, 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 93,140 units of the CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF (Material Number 332097). These connection devices are 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. This defect could compromise the administration of anesthetic fluids.

The affected products were distributed nationwide in the United States, as well as in Australia, Canada, Guatemala, and Kuwait. The recall involves specific batch numbers, including 61588414, 61587114, and 61590499. Healthcare providers and consumers should stop using the affected devices and contact B. Braun Medical for instructions on return or replacement.

The recalled product

Product
CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 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.
Category
Medical Device — Catheter Connectors
Hazard
Affected units
93,140

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 (20)

  • Batch: 61588414
  • 61587114
  • 61590499
  • 61591305
  • 61591822
  • 61592516
  • 61595497
  • 61596327
  • 61597457
  • 61598516
  • 61594208
  • 61600757
  • 61602063
  • 61609687
  • 61611125
  • 61612545
  • 61614791
  • 61615905
  • 61605299
  • 61616952

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 →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · leakage

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