The Recall Desk
HighFDA (Devices)·Z-1927-2017·Announced 2017-05-10

Dale Medical Stabilock Endotracheal Tube Holder Recall for Adhesive Failure

Dale Medical Products is recalling Stabilock Endotracheal Tube Holders because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

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 medical device failure that could lead to accidental extubation, a risk-of-harm scenario where injury has not yet been reported.

Plain-English summary

Dale Medical Products, Inc. is recalling the Stabilock Endotracheal Tube Holder, Product # 270. This device is a two-piece system consisting of an adhesive base and a cushioned neckband used to secure and stabilize endotracheal tubes to prevent accidental extubation.

The recall is being issued because the adhesive faceplate of the device may lose its adhesive properties, causing it to fail to adhere to the patient's face. This defect could compromise the device's ability to secure the endotracheal tube.

The recall affects 34,770 units distributed nationwide in the United States and internationally to Canada, Costa Rica, Norway, Paraguay, Ireland, Panama, Ecuador, Hong Kong, Malaysia, Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia. Affected lot numbers include 02 23 16, 04 11 16, 05 11 16, 02 24 16, 04 19 16, 05 13 16, 03 04 16, 04 20 16, 05 16 16, 03 07 16, 04 21 16, 05 18 16, 03 08 16, 05 03 16, 05 20 16, 03 10 16, 05 05 16, 05 24 16, 03 11 16, 05 06 16, 05 26 16, 04 07 16, 05 09 16, 05 31 16, 04 08 16, 05 10 16, and 06 02 16. Healthcare providers should stop using the affected devices and contact Dale Medical Products for instructions on return or replacement.

The recalled product

Product
Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attach
Manufacturer
Dale Medical Products, Inc.
Category
Medical Device — Airway Management
Hazard
Affected units
34,770

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 (20)

  • Lot Numbers: 02 23 16
  • 04 11 16
  • 05 11 16
  • 02 24 16
  • 04 19 16
  • 05 13 16
  • 03 04 16
  • 04 20 16
  • 05 16 16
  • 03 07 16
  • 04 21 16
  • 05 18 16
  • 03 08 16
  • 05 03 16
  • 05 20 16
  • 03 10 16
  • 05 05 16
  • 05 24 16
  • 03 11 16
  • 05 06 16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Dale Medical Products, 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 2 products in this recall →

Related recalls

Same manufacturer · Dale Medical Products, Inc.

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Same hazard · adhesive failure

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