The Recall Desk
HighFDA (Devices)·Z-3400-2018·Announced 2018-10-10

B. Braun Medical Recalls EC20CST 20G Soft Tip Catheter Connectors

B. Braun Medical is recalling EC20CST 20G Soft Tip 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 the EC20CST 20G CLSD Soft Tip Catheter, Material Number 333521. 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 units were distributed nationwide in the US and in Australia, Canada, Guatemala, and Kuwait.

Healthcare providers should stop using the affected catheter connectors and contact B. Braun Medical for further instructions. The recall covers specific batch numbers: 61600403, 61602663, 61608017, 61614723, and 61621770.

The recalled product

Product
EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 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 t
Affected units
10,275

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: 61600403
  • 61602663
  • 61608017
  • 61614723
  • 61621770

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 →