The Recall Desk
HighFDA (Devices)·Z-1928-2017·Announced 2017-05-10

Dale Medical Stabilock Endotracheal Adhesive Base Recalled for Adhesive Failure

Dale Medical Products is recalling Stabilock Endotracheal Adhesive Bases 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 failing to secure an endotracheal tube, which poses a risk of harm (accidental extubation) even though specific injury reports are not detailed in the provided text.

Plain-English summary

Dale Medical Products, Inc. is recalling the Stabilock Endotracheal Adhesive Base, product number 273. This device is a two-piece system used to secure and stabilize endotracheal tubes, preventing unnecessary movement that can help prevent accidental extubation. The recall involves 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.

The recall is being issued because the adhesive faceplate of the device may lose its adhesive properties and fail to adhere to the patient's face. The affected lot numbers are 04 07 16 04, 08 16, and 05 16 16. The agency has classified this as a Class II recall.

Healthcare facilities and consumers should stop using the affected products and contact Dale Medical Products, Inc. for instructions on return or replacement.

The recalled product

Product
Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 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 atta
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 (3)

  • Lot Numbers: 04 07 16 04
  • 08 16
  • 05 16 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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