What guidelines have been given?
All patients who have received treatments utilizing the ARROW Endurance Extended Dwell Peripheral Catheter System should reach out to their healthcare providers.
As for Medical facilities and Distributors, on May 19, 2023, Teleflex sent out an urgent recall letter to all customers giving detailed information on what to do with their devices and how to go forward.
Medical facilities are advised to:
- Verify inventory for any products included in the recall.
- Cease using and distributing the affected product immediately.
- Isolate the affected product in a designated quarantine area.
- Complete the acknowledgment form provided with the letter by checking the appropriate checkbox (affected product or no affected product). Fax the form to 1-855-419-8507, Attn: Customer Service, or email it to [email protected].
- If you possess the affected product, a customer service agent will reach out to you to provide a Return Goods Authorization (RGA) number and instructions for returning the product to Teleflex. Once the returned affected product is received, Teleflex (or the local dealer) will issue a credit note.
- When filling out the form, ensure that you only list batch numbers within the scope of the recall notice.
Distributors are advised to:
- Distribute copies of the Urgent Medical Device Recall letter to all customers who have received the affected product. Each customer must fill out and return the acknowledgment form to the distributor.
- Cease the use and distribution of the affected product immediately, and place it in quarantine. Arrange for the return of all products within the scope of the recall.
- Notify Teleflex once the required field activities outlined in the recall have been completed.
- After completing the necessary actions, submit the completed acknowledgment form to [email protected].
- When filling out the form, ensure that you only include batch numbers specified in the recall notice.
- If the product was distributed internationally, inform Teleflex Customer Service accordingly.
