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Recall Observatory FDA recall evidence

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

Z-1927-2017

March 24, 2017

Class II

Product summary

Firm
Dale Medical Products, Inc.
Event
Event 76965
Status
Terminated
Classification
Class II
Quantity
34,770 total
Official record key
device-enforcement:Z-1927-2017

Official wording

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

Code information: 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 , 05 26 16, 04 07 16, 05 09 16 , 05 31 16, 04 08 16, 05 10 16 , 06 02 16

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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