Saranas, Inc. recalls Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Recall date

August 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1684-2022

FDA classification

Class II

Brand / firm

Saranas, Inc.

Sold / distributed

US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)