The Recall Desk
HighFDA (Devices)·Z-3337-2018·Announced 2018-10-10

B. Braun Medical Recalls CE18HKST Catheter Connectors Due to Leakage

B. Braun Medical is recalling CE18HKST epidural catheter connectors because they 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, 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 14,520 units of the CE18HKST CONT EPID 20G SOFTIP (Material Number 332084). This connection device is 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. The affected products were distributed nationwide in the United States as well as in Australia, Canada, Guatemala, and Kuwait.

Healthcare providers and patients should stop using the affected connectors and contact B. Braun Medical for further instructions. The specific batch numbers involved in this recall are 61594211, 61597462, 61599654, 61604447, 61616727, 61620761, and 61622928.

The recalled product

Product
CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 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 with th
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Catheter Connectors
Hazard
Affected units
14,520

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 (7)

  • Batch: 61594211
  • 61597462
  • 61599654
  • 61604447
  • 61616727
  • 61620761
  • 61622928

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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