Argon Medical Devices, Inc recalls 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.
Recalled Product
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. 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 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
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