Tubing Pack Convenience Kit — Class II medical device recall Z-2550-2018
Terminated recall by Terumo Cardiovascular Systems Corp, reported 2018-08-01, distributed in FL. Kit was labeled with the incorrect Expiration Date of April 30, 2019.
| Recall number | Z-2550-2018 |
|---|---|
| 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 | 2017-05-12 |
| Classified | 2018-07-26 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2018-10-26 |
| Distributed | FL |
| Reason classes | labeling |
| Lot numbers | VE17 |
Product
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Reason for recall
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
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-2550-2018. 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.