Reported Nov 24, 2021 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The…
Arrow International 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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Arrow-Trerotola Over-The-Wire PTD
- Kit Percutaneous Thrombolytic Device7FR
- Product CodePT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
- Lot codes and dates
- Lot Number
13F19K036913F20A032313F20B013913F20C059413F20F008313F20F023013F20F057713F20H075613F20K084913F20L028313F20M018213F21A049813F21B015813F21C074713F21E0555
- Lot Number
- Amount recalled
- 1245 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Using this product could cause serious injury, illness or death — stop using it now.
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