The Recall Desk
HighFDA (Devices)·Z-3397-2018·Announced 2018-10-10

B. Braun Medical Recalls EC19CF Catheter Connectors Due to Leakage

B. Braun Medical is recalling EC19CF catheter connectors because they may not stay closed, causing 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, and the hazard involves a risk of harm (leakage/disconnection) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

B. Braun Medical, Inc. is recalling EC19CF 19G X 100CM CATH CLOSED TIP LF catheter connectors, Material Number 333512. The recall involves 16,400 units distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. The specific batch numbers affected are 61595460, 61598575, 61604885, 61608012, 61601770, 61611402, 61614722, 61616889, 61619490, and 61623870.

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. These devices are used by physicians to provide a common access point to a catheter for the delivery of anesthetics and fluids.

Healthcare providers and facilities should stop using the affected catheter connectors and contact B. Braun Medical for instructions on return or replacement. Consumers are not expected to have these devices in their homes, as they are medical supplies used in clinical settings.

The recalled product

Product
EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 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
Affected units
16,400

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: 61595460
  • 61598575
  • 61604885
  • 61608012
  • 61601770
  • 61611402
  • 61614722
  • 61616889
  • 61619490
  • 61623870

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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