The Recall Desk
HighFDA (Devices)·Z-3391-2018·Announced 2018-10-10

B. Braun Recalls Spinal and Epidural Catheter Connectors Due to Leakage

B. Braun Medical is recalling ES1827K 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 is classified as FDA Class II. The hazard involves a risk of harm (leakage/disconnection of anesthetic delivery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

B. Braun Medical, Inc. is recalling the ES1827K Spinal/Epidural Tray (LF), Material Number 333192. 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 recall was initiated 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 were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait.

Healthcare providers and facilities should stop using the affected product and contact B. Braun Medical, Inc. for instructions on how to return the product. The specific batch numbers affected are 61592518, 61600751, 61596330, 61603763, 61608873, 61612141, 61615216, 61619581, 61617800, and 61621835.

The recalled product

Product
ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 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 wit
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Anesthesia / Catheter
Hazard
Affected units
27,710

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 (10)

  • Batch: 61592518
  • 61600751
  • 61596330
  • 61603763
  • 61608873
  • 61612141
  • 61615216
  • 61619581
  • 61617800
  • 61621835

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 →

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