Cardiovascular Procedure Kit catalog # 76645 & 73806 — Class II medical device recall Z-0949-2022
Terminated recall by Terumo Cardiovascular Systems Corp, reported 2022-04-27, distributed nationwide. Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
| Recall number | Z-0949-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corp, Ashland, MA, United States |
| Recall initiated | 2022-02-03 |
| Classified | 2022-04-18 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2024-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 64 |
| UPC / GTIN / UDI-DI | 00699753477728, 00699753507685 |
| Lot numbers | Z15957677, Z16958398 |
| Model numbers | 73806, 76645 |
Product
Cardiovascular Procedure Kit catalog # 76645 & 73806
Reason for recall
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
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-0949-2022. 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.