The Recall Desk
HighFDA (Devices)·Z-3358-2018·Announced 2018-10-10

B. Braun Medical Recalls CE18TKDP Catheter Connectors Due to Leakage

B. Braun Medical is recalling CE18TKDP 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 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 11,010 units of CE18TKDP CONT EPID/DURAPREP catheter connectors, Material Number 332215. These connection devices are 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 batches are 61588161, 61592517, 61616704, and 61618683.

The products were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and users should stop using the affected connectors and contact B. Braun Medical for further instructions.

The recalled product

Product
CE18TKDP CONT EPID/DURAPREP, Material Number 332215 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 the
Affected units
11,010

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 (4)

  • Batch: 61588161
  • 61592517
  • 61616704
  • 61618683

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 →