FDA Recall Terminated

5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Recall: Z-0628-2022 · Initiated January 11, 2022

Recall

Recall Number: Z-0628-2022
Event Number: 89390
Firm: TELEFLEX MEDICAL INC
FEI Number: 3005747797
Product Code: QEW
Status: Terminated
Root Cause: Process change control
Initiated: January 11, 2022
Posted: February 15, 2022
Terminated: September 11, 2024
Address: 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

Description

Reason

The firm received reports indicating PTD tip separation during use.

Action

Arrow International LLC/Teleflex notified their consignees by letter on 01/11/2022. The letter explained the issue and requested that the consignee cease use and distribution. Distributors were directed to notify their customers. The firm is seeking return of the affected product. The following instructions were provided: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope to Teleflex. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. Important - Please ensure you only list batch numbers in scope of this Field Safety Notice when completing this form. 4. If you have further distr

Distribution

Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.

Quantity

5530 units