Arrow-Trerotola PTD Set recall
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous…
Why was Arrow-Trerotola PTD Set recalled?
The firm received reports indicating PTD tip separation during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous…
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 3668 units
- 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.
- Recall date
- February 23, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)