Saranas, Inc. Recall 90725
Description: Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Saranas, Inc. Recall 90725 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1684-2022 |
| Event ID | 90725 |
| Event Description | Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F) |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA. |
| Quantity | 953 |
| Recall 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. |
| Device Classification | 20220914 |
| Device Code Info | 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 |
| Center Classification Date | 20220907 |
| Recall Initiation Date | 20220810 |
| Recalling Firm | Saranas, Inc. |
| Initial Notification | Letter |
| Similar To |