Reported Sep 14, 2022 · Ongoing
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Saranas, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Saranas, Inc. · 2450 Holcombe Blvd Ste X · Houston, TX · 77021-2039
Is this the product you have?
- Early Bird Bleed Monitoring System Introducer Sheath Set
- REF
FG001-01 (6F)FG001-02 (8F)
- Lot codes and dates
2 of 2 products · 16 lot codes
Recalled lot codes, grouped by product number UDI REF Lot 00866532000402FG001-01510090S511110A510120F102422102445102531102671102685102731
00866532000419FG001-02515070A528090C510120G511110B102567102610102611
- Amount recalled
- 953
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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