| Date Initiated by Firm | September 20, 2021 |
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| Date Posted | November 18, 2021 |
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| Recall Status1 |
Terminated 3 on October 05, 2023 |
| Recall Number | Z-0234-2022 |
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| Recall Event ID |
88796 |
| 510(K)Number | K011056 |
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| Product Classification |
Catheter, embolectomy - Product Code DXE
|
| Product | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR
Product Code: PT-65709-WC
The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts |
|---|
| Code Information |
Lot Number:
13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229
13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379
13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415
13F21F1188 |
Recalling Firm/
Manufacturer |
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
|
| For Additional Information Contact | SAME
610-378-0131 |
|---|
Manufacturer Reason
for Recall | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. |
|---|
FDA Determined
Cause 2 | Unknown/Undetermined by firm |
|---|
| Action | Arrow International, a subsidiary of Teleflex issued an "URGENT - FIELD SAFETY NOTICE" consignee notification letter on 20th Sept 2021 via FedEx 2-day mail to medical facilities and distributors. Letter states reason for recall, health risk and action to take:
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 recalls@teleflex.com. 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.
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.
Should you require any further information or support concerning this issue, please contact: Customer Service Telephone: 1-866-396-2111; FAX: 1-855-419-8507 or E-mail: Recalls@teleflex.com.
|
|---|
| Quantity in Commerce | 1918 units |
|---|
| Distribution | Worldwide distribution: US (Nationwide) and OUS
(Foreign) to countries of:
BE
CA
CL
CZ
DE
ES
FR
IL
IT
KR
PH
SA
TR
TW
UK
|
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = DXE
|
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