Reported Feb 23, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component:…
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-65709-W containing componentPT-65709-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
27 of 27 products
Products covered by this recall # Barcodes Product as published 1 Lot number 13C19M0499 2 Lot Number / UDI: 13F20B0053 / (01)108019022121315 (17)220131 (10)13F20B0053, Components: Code PT-65709-C 3 Lot number 13C20A0970 4 10801902121315Lot Number / UDI: 13F20C0595 / (01)10801902121315 (17)220331 (10)13F20C0595, Components: Code PT-65709-C 5 Lot number 13C20C2089; Code PT-65709-C 6 Lot number 13C20C2082 7 10801902121315Lot Number / UDI: 13F20F0231 / (01)10801902121315 (17)220531 (10)13F20F0231, Components: Code PT-65709-C 8 Lot number 13C20F1139 9 10801902121315Lot Number / UDI: 13F20G0361 / (01)10801902121315 (17)220731 (10)13F20G0361, Components: Code PT-65709-C 10 Lot number 13C20G1199; Code PT-65709-C 11 Lot number 13C20G0228 12 10801902121315Lot Number / UDI: 13F20K0632 / (01)10801902121315 (17)221031 (10)13F20K0632, Components: Code PT-65709-C 13 Lot number 13C20H1675 14 10801902121315Lot Number / UDI: 13F21A0353 / (01)10801902121315 (17)221231 (10)13F21A0353, Components: Code PT-65709-C 15 Lot number 13C20M0639; Code PT-65709-C 16 Lot number 13C20J2689 17 10801902121315Lot Number / UDI: 13F21C0748 / (01)10801902121315 (17)230331 (10)13F21C0748, Components: Code PT-65709-C 18 Lot number 13C21C1696 19 10801902121315Lot Number / UDI: 13F21D0721 / (01)10801902121315 (17)230430 (10)13F21D0721, Components: Code PT-65709-C 20 Lot number 13C21C1696; Code PT-65709-C - Amount recalled
- 1265 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.
Want the full recall guide?
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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