Flo-Thru Intraluminal Shunt — Class II medical device recall Z-1019-2022
Terminated recall by Baxter Healthcare Corporation, reported 2022-05-11, distributed in AL, CA, KY, NY, OR, PA, TX. There is a potential for foreign matter.
| Recall number | Z-1019-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-04-29 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2026-07-10 |
| Distributed | AL, CA, KY, NY, OR, PA, TX |
| Countries outside the US | CH, GB, IT, JP, NL |
| Quantity | 300 devices |
| Reason classes | foreign material |
| Lot numbers | SP21J21-1584173 |
Product
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Reason for recall
There is a potential for foreign matter.
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-1019-2022. 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.