FDA-Device2024-09-18Class II
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
Bard Peripheral Vascular Inc
Hazard
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
Sold states
Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.
Affected count
625 units
Manufactured in
1625 W 3rd St Bldg 1, 850 W. Rio Salado Prkwy., Tempe, AZ, United States
Products
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3062-2024Don't want to check this manually?
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