Early Bird Bleed Monitoring System Introducer Sheath Set — Class II medical device recall Z-1684-2022
Ongoing recall by Saranas, Inc., reported 2022-09-14, distributed nationwide. Bleed monitoring system device design error, causing the device to not power on and complete the series of sel
| Recall number | Z-1684-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Saranas, Inc., Houston, TX, United States |
| Recall initiated | 2022-08-10 |
| Classified | 2022-09-07 |
| Reported by FDA | 2022-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 953 |
| UPC / GTIN / UDI-DI | 00866532000402, 00866532000419 |
| Lot numbers | 102422, 102445, 102531, 102567, 102610, 102611, 102671, 102685, 102731, 510120F, 510120G, 511110A, 511110B, 528090C |
| Model numbers | FG001-01 |
Product
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1684-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.