Arrow-Trerotola PTD Set recall
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device…
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: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378; Lot Number / UDI: 13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; Lot Number / UDI: 13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; Lot Number / UDI: 13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; Lot Number / UDI: 13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; Lot Number / UDI: 13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; Lot Number / UDI: 13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; Lot Number / UDI: 13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; Lot Number / UDI: 13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; Lot Number / UDI: 13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; Lot Number / UDI: 13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; Lot Number / UDI: 13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; Lot Number / UDI: 13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; Lot Number / UDI: 13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; Lot Number / UDI: 13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; Lot Number / UDI: 13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; Lot Number / UDI: 13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; Lot Number / UDI: 13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; Lot Number / UDI: 13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; Lot Number / UDI: 13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; Lot Number / UDI: 13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; Lot Number / UDI: 13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; Lot Number / UDI: 13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; Lot Number / UDI: 13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; Lot Number / UDI: 13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; Lot Number / UDI: 13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; Lot Number / UDI: 13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; Lot Number / UDI: 13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; Lot Number / UDI: 13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; Lot Number / UDI: 13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; Lot Number / UDI: 13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; Lot Number / UDI: 13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; Lot Number / UDI: 13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898
- Product
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device…
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 14583 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)