Argon Medical Devices, Inc recalls 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5
Recalled Product
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Hazard / Issue
The stiffness of the soft end of the guidewire caused tissue perforation.
Issued by
FDA
Distribution: No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Lot/Code Info: Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.
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