Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Early Bird Bleed Monitoring System Introducer Sheath Set Recalled by Saranas, Inc. Due to Bleed monitoring system device design error, causing the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Saranas, Inc. directly.
Affected Products
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Quantity: 953
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Saranas, Inc.
Saranas, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report