| | Class 1 Device Recall ArrowTrerotola Percutaneous Thrombolytic Device |  |
| Date Initiated by Firm | January 11, 2022 |
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| Date Posted | February 15, 2022 |
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| Recall Status1 |
Terminated 3 on September 11, 2024 |
| Recall Number | Z-0626-2022 |
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| Recall Event ID |
89390 |
| 510(K)Number | K011056 |
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| Product Classification |
Peripheral mechanical thrombectomy with aspiration - Product Code QEW
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| Product | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS
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. |
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| Code Information |
Lot Number / UDI:
13F20C0596 / (01)10801902121308 (17)220331 (10)13F20C0596, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20B1435; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C20C1558;
Lot Number / UDI:
13F20F0081 / (01)10801902121308 (17)220531 (10)13F20F0081, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C20C1558;
Lot Number / UDI:
13F20F0229 / (01)10801902121308 (17)220531 (10)13F20F0229, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F0570; Code PT-03009, Lot number 13C20C1558;
Lot Number / UDI:
13F20F0509 / (01)10801902121308 (17)220531 (10)13F20F0509, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20F0570;
Lot Number / UDI:
13F20F0578 / (01)10801902121308 (17)220630 (10)13F20F0578, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HS, Lot number 14C20D1061; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20F1138;
Lot Number / UDI:
13F20G0177 / (01)10801902121308 (17)220630 (10)13F20G0177, Components: Code PT-65709-C, Lot number 13C20G0228; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20G0238
Lot Number / UDI:
13F20G0566 / (01)10801902121308 (17)220630 (10)13F20G0566, Components: Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0864; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585;
Lot Number / UDI:
13F20H0531 / (01)10801902121308 (17)220831 (10)13F20H0531, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20G0395; Code PT-03009, Lot number 13C20G1198; Code PT-03009, Lot number 13C20G0864;
Lot Number / UDI:
13F20J0379 / (01)10801902121308 (17)220831 (10)13F20J0379, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20H0604;
Lot Number / UDI:
13F20L0514 / (01)10801902121308 (17)221031 (10)13F20L0514, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HS, Lot number 14C20H0384; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20L0871; Code PT-03009, Lot number 13C20L0872;
Lot Number / UDI:
13F21A0354 / (01)10801902121308 (17)221231 (10)13F21A0354, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144;
Lot Number / UDI:
13F21C0081 / (01)10801902121308 (17)230228 (10)13F21C0081, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21B1533; Code PT-03009, Lot number 13C21A0855;
Lot Number / UDI:
13F21C0749 / (01)10801902121308 (17)230331 (10)13F21C0749, Components: Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 13C21C1696; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533;
Lot Number / UDI:
13F21D0870 / (01)10801902121308 (17)230430 (10)13F21D0870, Components: Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21C0327;
Lot Number / UDI:
13F21E0415 / (01)10801902121308 (17)230430 (10)13F21E0415, Components: Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21C0476; Code PT-65709-HS, Lot number 14C21B0690; Code PT-03009, Lot number 13C21C2397; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533;
Lot Number / UDI:
13F21F1188 / (01)10801902121308 (17)230630 (10)13F21F1188, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21E0722 |
Recalling Firm/
Manufacturer |
TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
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Manufacturer Reason
for Recall | The firm received reports indicating PTD tip separation during use. |
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FDA Determined
Cause 2 | Process change control |
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| 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 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.
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 |
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| Quantity in Commerce | 1874 units |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = QEW
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