The Recall Desk
HighFDA (Devices)·Z-3378-2018·Announced 2018-10-10

B. Braun Medical Recalls 18GA Safety Tuohy Needle Trays

B. Braun Medical is recalling 2,070 units of 18GA Safety Tuohy Needle 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 defect (disconnection/leakage) that poses a risk of harm to patients, 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 2,070 units of CE18TKY 18GA Safety Tuohy Needle Trays (Material Number 332266). These connection devices are used by physicians to provide a common access point to a catheter for the delivery of anesthetics and fluids. The affected batches are 61597444, 61603111, and 61618684.

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. This defect could compromise the integrity of the anesthetic or fluid administration process.

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

The recalled product

Product
CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 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
2,070

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 (3)

  • Batch: 61597444
  • 61603111
  • 61618684

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 · disconnection

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