Reported Feb 23, 2022 · Terminated
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola…
Teleflex Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX MEDICAL INC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) 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.
- Lot codes and dates
52 of 52 products
Products covered by this recall # Barcodes Product as published 1 0080190201315613F20A0286 / (01)00801902013156(17)211231(10)13F20A0286 2 00801902013156Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426 3 00801902013156Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640 4 00801902013156Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141 5 00801902013156Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276 6 00801902013156Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353 7 00801902013156Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424 8 00801902013156Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352 9 00801902013156Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425 10 00801902013156Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426 11 00801902013156Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122 12 00801902013156Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123 13 00801902013156Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124 14 00801902013156Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403 15 00801902013156Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204 16 00801902013156Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232 17 00801902013156Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389 18 00801902013156Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353 19 00801902013156Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729 20 00801902013156Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378 - Amount recalled
- 14583 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
The firm received reports indicating PTD tip separation during use.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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