Recall Z-1928-2017— Dale Medical Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Dale Medical Products, Inc., initiated 2017-03-24, terminated 2018-05-21. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face..
- Recalling firm
- Dale Medical Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-24
- Terminated
- 2018-05-21
- Firm location
- Plainville, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.