Recall Z-1684-2022— Saranas, Inc.
Class II · Ongoing
Class II FDA medical device recall by Saranas, Inc., initiated 2022-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F). Reason: 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..
- Recalling firm
- Saranas, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-10
- Firm location
- Houston, TX, United States
Product description
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.