| | 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-0627-2022 |
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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 PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T
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:
13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C19M0193;
Lot Number / UDI:
13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C20A1583; Code PT-45509-T, Lot number 13C19M0193;
Lot Number / UDI:
13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527, Components: Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-S6, Lot number 14C20A0602;
Lot Number / UDI:
13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20C0842;
Lot Number / UDI:
13F20D0127 / (01)10801902121261(17)220331(10)13F20D0127, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-T, Lot number 13C20D0847;
Lot Number / UDI:
13F20D0402 / (01)10801902121261(17)220430(10)13F20D0402, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20D2088;
Lot Number / UDI:
13F20F0390 / (01)10801902121261(17)220531(10)13F20F0390, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20E0902;
Lot Number / UDI:
13F20G0285 / (01)10801902121261(17)220630(10)13F20G0285, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number PT-45509-T; Code 13C20G0868,
Lot Number / UDI:
13F20J0545 / (01)10801902121261(17)220831(10)13F20J0545, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20G1979;
Lot Number / UDI:
13F20J0933 / (01)10801902121261(17)220930(10)13F20J0933, Components: Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577;
Lot Number / UDI:
13F20K0851 / (01)10801902121261(17)221031(10)13F20K0851, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577;
Lot Number / UDI:
13F20M0174 / (01)10801902121261(17)221120(10)13F20M0174, Components: Code PT-45509-S6, Lot number 14C20K1177; Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807;
Lot Number / UDI:
13F21A0662 / (01)10801902121261(17)230131(10)13F21A0662, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807;
Lot Number / UDI:
13F21C0079 / (01)10801902121261(17)230228(10)13F21C0079, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20J0354;
Lot Number / UDI:
13F21C0751 / (01)10801902121261(17)230331(10)13F21C0751, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-T, Lot number 13C21C1697; Code PT-45509-T, Lot number 13C21B0771;
Lot Number / UDI:
13X21D0027 / (01)10801902121261(17)230430(10)13X21D0027, Components: Code PT-45509-S6, Lot number 14X21D0003; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-T, Lot number 13X21D0009;
Lot Number / UDI:
13F21F0399 / (01)10801902121261(17)230531(10)13F21F0399, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21D0675; Code PT-45509-T, Lot number 13C21E0717;
Lot Number / UDI:
13F21G0226 / (01)10801902121261(17)230630(10)13F21G0226, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205;
Lot Number / UDI:
13F21G1343 / (01)10801902121261(17)230731(10)13F21G1343, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205;
Lot Number / UDI:
13F21H0639 / (01)10801902121261(17)230731(10)13F21H0639, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-S6, Lot number 14C21G1307; Code PT-45509-T, Lot number 13C21H0942;
Lot Number / UDI:
13F21H1272 / (01)10801902194067(17)230831(10)13F21H1272, Components: Code PT-45509-T2, Lot number 13C21H2037; Code PT-45509-S7, Lot number 14C21H0978;
Lot Number / UDI:
13F21L0900 / (01)10801902194067(17)231130(10)13f21l0900, Components: Code PT-45509-T2, Lot number 13C21L1103; Code PT-45509-S7, Lot number 14C21H1310 |
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 | 3668 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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