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U.S. Department of Health and Human Services

Class 2 Device Recall Dale Medical Stabilock Endotracheal Tube Holder

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  Class 2 Device Recall Dale Medical Stabilock Endotracheal Tube Holder see related information
Date Initiated by Firm March 24, 2017
Create Date May 03, 2017
Recall Status1 Terminated 3 on May 21, 2018
Recall Number Z-1927-2017
Recall Event ID 76965
Product Classification Device, fixation, tracheal tube - Product Code CBH
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
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
Recalling Firm/
Manufacturer		 Dale Medical Products, Inc.
7 Cross St
Plainville MA 02762-1525
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
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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