Arrow-Trerotola Over-The-Wire PTD Kit recall
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS…
Why was Arrow-Trerotola Over-The-Wire PTD Kit 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: 13F20A0323 / (01)108019022121292 (17)211231 (10)13F20A0323, Components: Code PT-65709-C, Lot number 13C19M0499; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C19J1873; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19J0572; Code PT-03009, Lot number 13C19K0832; Lot Number / UDI: 13F20B0139 / (01)10801902121292 (17)220131 (10)13F20B0139, Components: Code PT-65709-C, Lot number 13C20A0970; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19G0671; Code PT-03009, Lot number 13C19L0622; Lot Number / UDI: 13F20C0594 / (01)10801902121292 (17)220331 (10)13F20C0594, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F008 3/ (01)10801902121292 (17)220531 (10)13F20F0083, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-03009, Lot number 13C20C1558; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F0230 / (01)10801902121292 (17)220531 (10)13F20F0230, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20F0577 / (01)10801902121292 (17)220630 (10)13F20F0577, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20F1138; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20H0756 / (01)10801902121292 (17)220831 (10)13F20H0756, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20H0604; Code PT-03009, Lot number 13C20G1198; Lot Number / UDI: 13F20K0849 / (01)10801902121292 (17)221031 (10)13F20K0849, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-03009, Lot number 13C20H0604; Lot Number / UDI: 13F20L0283 / (01)10801902121292 (17)221031 (10)13F20L0283, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI: 13F20M0182 / (01)10801902121292 (17)221231 (10)13F20M0182, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C20L0871; Lot Number / UDI: 13F21A0498 / (01)10801902121292 (17)221231 (10)13F21A0498, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21B0158 / (01)10801902121292 (17)230131 (10)13F21B0158, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21C0747 / (01)10801902121292 (17)230331 (10)13F21C0747, Components: Code PT-65709-C, Lot number 13C21C0326; Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21E0555 / (01)108019021212292 (17)230430 (10)13F21E0555, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-HFS, Lot number 14C21C0895; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C2397
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS…
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 1400 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)