Reported Feb 23, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, 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?
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC
- containing componentsPT-12709-CA, PT-12709-C, 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
36 of 36 products
Products covered by this recall # Barcodes Product as published 1 Lot number 13C19K2024; Code PT-65709-HS 2 Lot number 14C19K1035; Code PT-03009 3 Lot number 13C19J1873 4 10801902121254Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components: Code PT-12709-C 5 Lot number 13C20C0498; Code PT-65709-HS 6 Lot number 14C19K1035; Code PT-03009 7 Lot number 13C19L0622; Code PT-03009 8 Lot number 13C19M0278; Code PT-03009 9 Lot number 13C19J1873 10 10801902121254Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components: Code PT-12709-C 11 Lot number 13C20G0230; Code PT-65709-HS 12 Lot number 14C20D1061; Code PT-03009 13 Lot number 13C20G0238; Code PT-03009 14 Lot number 13C20F2585 15 10801902121254Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components: Code PT-12709-C 16 Lot number 13C20J0307; Code PT-65709-HS 17 Lot number 14C20H0384; Code PT-03009 18 Lot number 13C20L0872 19 10801902121254Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components: Code PT-12709-C 20 Lot number 13C20J0307; Code PT-65709-HS - Amount recalled
- 676 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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