Agency classClass IIOur severity:High FDA (Devices)·Z-3359-2018·Announced 2018-10-10

B. Braun Medical Recalls CE18TKPS Epidural Catheter Connectors

B. Braun Medical is recalling CE18TKPS epidural catheter connectors because they 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 is classified as FDA Class II. The hazard involves a medical device failure (leakage/disconnection) that poses a risk of harm, but the source text does not report 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 CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216. 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 affected units are identified by batch numbers 61598355, 61605294, 61611451, 61616567, and 61619580.

A total of 13,890 units were distributed worldwide, including the United States (nationwide), Australia, Canada, Guatemala, and Kuwait. Healthcare providers and facilities should stop using the affected devices and contact B. Braun Medical for further instructions.

The recalled product

Product: CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 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: 13,890

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 (5)

Batch: 61598355
61605294
61611451
61616567
61619580

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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