TELEFLEX MEDICAL INC Recall 89390
Description: 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.
TELEFLEX MEDICAL INC Recall 89390 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0626-2022 |
| Event ID | 89390 |
| Event Description | 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. |
| Product Type | Devices |
| 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 | 1874 units |
| Recall Reason | The firm received reports indicating PTD tip separation during use. |
| Device Classification | 20220223 |
| Device Code Info | 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 |
| Center Classification Date | 20220215 |
| Recall Initiation Date | 20220111 |
| Recalling Firm | TELEFLEX MEDICAL INC |
| Initial Notification | Letter |
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