The Recall Desk
HighFDA (Devices)·Z-3333-2018·Announced 2018-10-10

B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage

B. Braun Medical is recalling CE17TKFC Epidural Trays 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 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 where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling CE17TKFC Epidural Trays with 17GA Tuohy needles (Material Number 332079). 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 delivery of anesthetic fluids.

The affected units were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. The recall includes 69,750 units across 21 specific batch numbers. Healthcare providers and patients should stop using these devices and contact B. Braun Medical for instructions on replacement or return.

The recalled product

Product
CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 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
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Anesthesia / Catheter
Hazard
Affected units
69,750

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: 61588411
  • 61589132
  • 61590240
  • 61591302
  • 61591816
  • 61592013
  • 61592513
  • 61594212
  • 61595169
  • 61595496
  • 61596322
  • 61596323
  • 61597455
  • 61597456
  • 61618678
  • 61614704
  • 61618680
  • 61618681
  • 61621829
  • 61621830

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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