Reported Jun 3, 2020 · Terminated
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage:…
Argon Medical Devices, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
2 of 2 products · 2 lot codes
| REF | UDI |
|---|---|
651506300 |
|
655506300 |
|
- Lot codes and dates
- REF /LOT
651506300/ 112678651127139711277305112878251129334911288772112903871126319911262264112587781125494211253443
- REF/ LOT
655506300 / 11268009112847761126659211285976112878261128035911260512112528431124858311277295
- REF /LOT
- Amount recalled
- 15,795 units
Why it was recalled
Tungsten coils of the guidewire included in the introducer kit were detaching.
This product could cause temporary or reversible health problems — stop using it.
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