Recall Z-1928-2017 ยท CBH Device, Fixation, Tracheal Tube
Dale Medical Products, Inc.
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 movemen
| Date | Mar 24, 2017 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.