FDA-Device2015-12-23Class II
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
Edwards Lifesciences, LLC
Hazard
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
Sold states
US
Affected count
147,350 units
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2016Don't want to check this manually?
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