Agency classClass IIOur severity:High FDA (Devices)·Z-3393-2018·Announced 2018-10-10

B. Braun Medical Recalls Spinal and Epidural Catheter Connectors

B. Braun Medical is recalling ES1827KDS Spinal/Epidural Full Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 specific injuries or illnesses, aligning with 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 ES1827KDS Spinal/Epidural Full Kit (Material Number 333194). 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 continuous administration of anesthetic fluids.

The recall is being conducted 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 recall affects 10,320 units distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. The affected batches are 61592525, 61596331, 61601859, 61608500, 61611126, 61614295, 61618117, and 61621832. Healthcare providers and consumers should stop using the affected products and contact B. Braun Medical, Inc. for further instructions.

The recalled product

Product: ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 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 — Catheter Connectors
Hazard: leakage
disconnection
Affected units: 10,320

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 (8)

Batch: 61592525
61596331
61601859
61608500
61611126
61614295
61618117
61621832

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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