Prestige Plus 185cm J-Tip: Part number: 9185J — Class II medical device recall Z-1845-2015
Terminated recall by Volcano Corporation, reported 2015-07-01, distributed nationwide. During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in ac
| Recall number | Z-1845-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-06-25 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 162 total |
| Reason classes | labeling |
| Lot numbers | 50004551/005-060 |
| Serial numbers | 005-060 |
| Model numbers | 9185J |
Product
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Reason for recall
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
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-1845-2015. 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.