FDA-Device2022-10-05Class II
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Cook Incorporated
Hazard
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
488 US, 5 OUS
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2022Don't want to check this manually?
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