Device product
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Z-1684-2022
Product summary
- Firm
- Saranas, Inc.
- Event
- Event 90725
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 953
- Official record key
device-enforcement:Z-1684-2022
Official wording
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.
Code information: UDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611
Distribution pattern: US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Derived failure modes
-
Device software or design
design error