Cardiovascular Procedure Kit — Class II medical device recall Z-0966-2019
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2019-03-06, distributed in TX. Presence of natural rubber latex is not declared in the label
| Recall number | Z-0966-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-27 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2019-08-20 |
| Distributed | TX |
| Quantity | 12 packages |
| Reason classes | undeclared allergen, labeling |
| Lot numbers | A30 |
| Model numbers | 140222 |
Product
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Reason for recall
Presence of natural rubber latex is not declared in the label
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-0966-2019. 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.