FDAAugust 10, 2022device
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
saranas
UPCs
0086653200040200866532000419
Recall history
No related federal recalls on record for this brand yet.
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