FDA-Device2024-01-17Class II
BD Recanalization System, REF: BDRECANSYSTEM
Bard Peripheral Vascular Inc
Hazard
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Sold states
US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN
Affected count
403
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
BD Recanalization System, REF: BDRECANSYSTEM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2024Don't want to check this manually?
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