| Class 2 Device Recall Device, fixation, tracheal tube | |
Date Initiated by Firm | March 24, 2017 |
Create Date | May 03, 2017 |
Recall Status1 |
Terminated 3 on May 21, 2018 |
Recall Number | Z-1928-2017 |
Recall Event ID |
76965 |
Product Classification |
Device, fixation, tracheal tube - Product Code CBH
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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 attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation |
Code Information |
Lot Numbers: 04 07 16 04, 08 16, 05 16 16 |
Recalling Firm/ Manufacturer |
Dale Medical Products, Inc. 7 Cross St Plainville MA 02762-1525
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For Additional Information Contact | 508-695-9316 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
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 |
Quantity in Commerce | 34,770 total |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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