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Argon Medical Devices, Inc recalls 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE E
Recalled May 13, 2020 · FDA recall Z-1791-2020 · Argon Medical Devices
Hazard
The stiffness of the soft end of the guidewire caused tissue perforation. · FDA Class I
Units
1690 units
Sold at
No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Description
The stiffness of the soft end of the guidewire caused tissue perforation.
Product
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Manufacturer(s)
Argon Medical Devices, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →