Recall record at a glance
| Official record | Z-1928-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Dale Medical Products, Inc. |
| Report date | May 10, 2017 |
| Recall initiation date | Mar 24, 2017 |
| Quantity | 34,770 total |
| Location | Plainville, MA, United States |
Official 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
Why the product was recalled
ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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