Intravascular — Class II medical device recall Z-0446-2016
Terminated recall by Edwards Lifesciences, LLC, reported 2015-12-23. Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additiona
| Recall number | Z-0446-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2015-11-13 |
| Classified | 2015-12-17 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2016-07-15 |
| Quantity | 147,350 units |
| Model numbers | 54IV12, 54IV22, 54IV32, 54IV42, MK132, MK2156, MK2227, MK2270, MK2292, MK2300, MK2374, MK2394, MK2450, MK2508 |
Product
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
Reason for recall
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
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-0446-2016. 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.