Reported Feb 23, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC 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-65709-HFWC containing componentsPT-65709-C, PT-03009, PT-65709-HFS 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
67 of 67 products
Products covered by this recall # Barcodes Product as published 1 13F20A0323 / (01)108019022121292 (17)211231 (10)13F20A0323, Components: Code PT-65709-C, Lot number 13C19M0499 2 Code PT-65709-HFS, Lot number 14C19J0342 3 Code PT-03009, Lot number 13C19J1873 4 Code PT-03009, Lot number 13C19L0622 5 Code PT-03009, Lot number 13C19J0572 6 Code PT-03009, Lot number 13C19K0832 7 10801902121292Lot Number / UDI: 13F20B0139 / (01)10801902121292 (17)220131 (10)13F20B0139, Components: Code PT-65709-C, Lot number 13C20A0970 8 Code PT-65709-HFS, Lot number 14C20A0611 9 Code PT-65709-HFS, Lot number 14C19G0671 10 Code PT-03009, Lot number 13C19L0622 11 10801902121292Lot Number / UDI: 13F20C0594 / (01)10801902121292 (17)220331 (10)13F20C0594, Components: Code PT-65709-C, Lot number 13C20C2082 12 Code PT-65709-HFS, Lot number 14C20A0611 13 Code PT-65709-HFS, Lot number 14C19J0342 14 Code PT-03009, Lot number 13C20B1435 15 10801902121292Lot Number / UDI: 13F20F008 3/ (01)10801902121292 (17)220531 (10)13F20F0083, Components: Code PT-65709-C, Lot number 13C20F0572 16 Code PT-65709-HFS, Lot number 14C20D1060 17 Code PT-65709-HFS, Lot number 14C20A0611 18 Code PT-03009, Lot number 13C20C1558 19 Code PT-03009, Lot number 13C20B1435 20 10801902121292Lot Number / UDI: 13F20F0230 / (01)10801902121292 (17)220531 (10)13F20F0230, Components: Code PT-65709-C, Lot number 13C20F1139 - Amount recalled
- 1400 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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