Reported Feb 23, 2022 · Terminated
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components:…
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?
- 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device
- REF PT-65509-HFC containing componentsPT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) 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
153 of 153 products
Products covered by this recall # Barcodes Product as published 1 1080190212128513F20A0359 / (01)10801902121285(17)211231(10)13F20A0359, Components: Code PT-65509-S, Lot number 14C19H0644 2 Code PT-65509-S, Lot number 14C19L1402 3 Code PT-03000, Lot number 13C19J0203 4 Code PT-01000-D, Lot number 13C19L2034 5 10801902121285Lot Number / UDI: 13F20A0519 / (01)10801902121285(17)211131(10)13F20A0519, Components: Code PT-65509-S, Lot number 14C19L1402 6 Code PT-03000, Lot number 13C19J0203 7 Code PT-03000, Lot number 13C19M0279 8 Code PT-01000-D, Lot number 13C20A0986 9 10801902121285Lot Number / UDI: 13F20B0140 / (01)10801902121285(17)220131(10)13F20B0140, Components: Code PT-65509-S, Lot number 14C19L1402 10 Code PT-03000, Lot number 13C19M0279 11 Code PT-03000, Lot number 13C19M0954 12 Code PT-01000-D, Lot number 13C20A2408 13 10801902121285Lot Number / UDI: 13F20B0423 / (01)10801902121285(17)220228(10)13F20B0423, Components: Code PT-65509-S, Lot number 14C19L1402 14 Code PT-03000, Lot number 13C19M0954 15 Code PT-03000, Lot number 13C20A0627 16 Code PT-01000-D, Lot number 13C20B1758 17 10801902121285Lot Number / UDI: 13F20C0223 / (01)10801902121285(17)220228(10)13F20C0223, Components: Code PT-65509-S, Lot number 14C19L1402 18 Code PT-03000, Lot number 13C19M0954 19 Code PT-03000, Lot number 13C20A0627 20 Code PT-01000-D, Lot number 13C20B2334 - Amount recalled
- 5530 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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