Reported May 13, 2020 · Terminated
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE…
Argon Medical Devices, 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: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
- 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm
- REF/UDI114135080/(01)208863333008067. RxOnly STERILE EO
- Lot codes and dates
- Guidewire Model 114135080
- LOT numbers
112358951123447611237014and 11240602
- Amount recalled
- 1690 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
The stiffness of the soft end of the guidewire caused tissue perforation.
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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