The Recall Desk
HighFDA (Devices)·Z-3394-2018·Announced 2018-10-10

B. Braun Medical Recalls Espocan Spinal/Epidural Trays Due to Leakage

B. Braun Medical is recalling Espocan Spinal/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 with a functional 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 the ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196. This product is a connection device 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 are identified by the following batch numbers: 61585920, 61588417, 61592015, 61595500, 61600749, 61603117, 61608504, 61611452, 61613685, 61616404, 61618408, 61623650, and 61620984.

A total of 35,680 units were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare providers and facilities should stop using the affected trays and contact B. Braun Medical for instructions on how to return or dispose of the product.

The recalled product

Product
ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 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
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Anesthesia/Fluid Administration
Hazard
Affected units
35,680

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 (13)

  • Batch: 61585920
  • 61588417
  • 61592015
  • 61595500
  • 61600749
  • 61603117
  • 61608504
  • 61611452
  • 61613685
  • 61616404
  • 61618408
  • 61623650
  • 61620984

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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