Z-1928-2017 Class II Terminated

Recalled by Dale Medical Products, Inc. — Plainville, MA

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
March 24, 2017
Termination Date
May 21, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,770 total

Product Description

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

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.

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.

Code Information

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