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Terminated

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 attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

FDA Recall Z-1928-2017 · Posted None

Recalling FirmDale Medical Products, Inc.
Recall StatusTerminated
Product CodeCBH
Date Initiated2017-03-24
Date Terminated2018-05-21
Product Quantity34,770 total

Reason for Recall

ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.

Firm Action

Dale Medical notified accounts (OUS) on March 24, 2017 and US accounts on April 7, 2017 advising them to review inventory, if you have any of the noted Lot numbers in stock contact your customers that may have received the identified lot numbers of 270 ET Tube holders and remove suspected product.. Dale Medical will replace product. For questions customers were instructed to call 508-695-9316 ext. 143

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -US ( Nationwide) and Internationally to Canada, Costa Rica, Norway, Paraguay, Ireland, Panama, Ecuador, Hong Kong, Malaysia, Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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