Food, drugs, devices › Edwards Lifesciences, LLC
Device recall: Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292,
FDA enforcement event 72690 is a device recall by Edwards Lifesciences, LLC of Irvine, CA, initiated 13 Nov 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 15 Jul 2016. Initiation: voluntary: firm initiated. Edwards Lifesciences, LLC has 50 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Edwards Lifesciences, LLC, Irvine, CA.
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."
Distribution
"US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0446-2016 | Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227 | 147,350 units | Class II | Terminated | 23 Dec 2015 |
Context
Other enforcement events for Edwards Lifesciences, LLC
All 50 events for Edwards Lifesciences, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Jul 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.