Reported May 13, 2020 · Terminated
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. 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)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm
- REF/UDI114135150/(01)20886333008074. RxOnly.STERILE EO
- Lot codes and dates
- Guidewire Model 114135150
- LOT numbers
112487181125120411260495. 112687411124266711241250 and 11239540
- Amount recalled
- 1190 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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