FDA-Device2022-09-14Class II
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Saranas, Inc.
Hazard
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Sold states
US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Affected count
953
Manufactured in
2450 Holcombe Blvd Ste X, N/A, Houston, TX, United States
Products
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2022Don't want to check this manually?
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