FDA Medical Device Recalls (openFDA)
Dale Medical Products, Inc.: 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
- Recall number
- Z-1927-2017
- Recalling firm
- Dale Medical Products, Inc.
- 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
- Status
- Terminated
- Initiated
- 2017-03-24
- Posted
- not on file
- Terminated
- 2018-05-21
- Reason
- ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBH
- Firm FEI
- 1214422
- Firm city
- Plainville
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28