The Recall Desk
HighFDA (Devices)·Z-3344-2018·Announced 2018-10-10

B. Braun Recalls CE17TKFS Epidural Trays Due to Connector Leakage

B. Braun Medical is recalling CE17TKFS Epidural Trays because the catheter connectors 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 without reported injury.

Plain-English summary

B. Braun Medical, Inc. is recalling 24,810 units of the CE17TKFS Epidural Tray (Material Number 332098). 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 United States and in Australia, Canada, Guatemala, and Kuwait. The specific batch numbers involved are 61586632, 61591151, 61594892, 61599653, 61604114, 61608068, 61612419, 61615748, and 61619582. Healthcare providers should stop using these devices and contact the manufacturer for instructions.

The recalled product

Product
CE17TKFS EPIDURAL TRAY, Material Number 332098 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 cathe
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Anesthesia / Catheter
Hazard
Affected units
24,810

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 (9)

  • Batch: 61586632
  • 61591151
  • 61594892
  • 61599653
  • 61604114
  • 61608068
  • 61612419
  • 61615748
  • 61619582

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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