Z-1928-2017Class II

Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder...

Name: Z-1928-2017 Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder...
Creator: Dale Medical Products, Inc.
Published: 2017-03-24
License: https://open.fda.gov/license/

Dale Medical Products, Inc. / initiated 2017-03-24 / Terminated / root cause: manufacturing process

FDA source

Dale Medical Products, Inc. began a recall of Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive... on 2017-03-24. FDA classified it as Class II and gives the reason as "ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1928-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-24
Posted: 2017-05-03
Terminated: 2018-05-21
Recalling firm: Dale Medical Products, Inc.
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
Product code: CBH Device, Fixation, Tracheal Tube
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lot Numbers: 04 07 16 04, 08 16, 05 16 16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1928-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-03
Z-1928-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-03

Product code CBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)