FDA-Device2020-05-13Class I
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Argon Medical Devices, Inc
Hazard
The stiffness of the soft end of the guidewire caused tissue perforation.
Sold states
No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Affected count
1690 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1791-2020Don't want to check this manually?
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