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Early Bird Bleed Monitoring System
SARANAS INC. · Model FG001-01 · UDI-DI 00866532000402
QFJ
Prescription
1
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
0
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-10 | Saranas, Inc. | 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 |
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