Baxter Flo-Rester — Class II medical device recall Z-0656-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-01-17, distributed nationwide. Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below
| Recall number | Z-0656-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-12-06 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
Product
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM, 2.25 MM GLOBAL; f) Product Code 50250: 12MM, 2.50 MM GLOBAL; g) Product Code 50275: 12MM, 2.75 MM GLOBAL; h) Product Code 50300: 12MM, 3.00 MM GLOBAL; i) Product Code 50350: 12MM, 3.50 MM GLOBAL; j) Product Code 50400: 12MM, 4.00 MM GLOBAL; k) Product Code 60100: 30MM, 1.00 MM GLOBAL; l) Product Code 60175: 30MM, 1.75 MM GLOBAL; m) Product Code 60275: 30MM, 2.75 MM GLOBAL; n) Product Code 60300: 30MM, 3.00 MM GLOBAL; o) Product Code 60350: 30MM, 3.50 MM GLOBAL; p) Product Code 50125: 12MM, 1.25 MM GLOBAL; q) Product Code 50450BIOS: 12MM, 4.50 MM GLOBAL; r) Product Code 60125BIOS: 30MM, 1.25 MM GLOBAL; s) Product Code 60150BIOS: 30MM, 1.50 MM GLOBAL; t) Product Code 60200BIOS: 30MM, 2.00 MM GLOBAL; u) Product Code 60225BIOS: 30MM, 2.25 MM GLOBAL; v) Product Code 60250BIOS: 30MM, 2.50 MM GLOBAL; w) Product Code 60400BIOS: 30MM, 4.00 MM GLOBAL; x) Product Code 60450BIOS: 30MM, 4.50 MM GLOBAL
Reason for recall
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
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-0656-2024. 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.