Reported Dec 23, 2015 · Terminated
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270,…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
Intravascular (IV) Administration SetsModel No. 54IV1254IV2254IV32MK245054IV42MK132MK2156MK2270MK2292MK2300MK2374MK2394MK2508MK2227
- Lot codes and dates
1,729 of 1,729 codes
599636165996361659963616599636165996361659963616599636165996361659963616599636166006212459736951596821615968216159727259597272595972725959391951593919515939195159391951593919515940767059407670594076705940767059407670594076705940767059464977594649775946497759464977594649775946497759474664594746645947466459474664594811765948117659523673595236735952367359523673595236735954097759540977595409775954097759540977595660315956603159566031595660315956603159579648595796485957964859579648
- Amount recalled
- 147,350 units
Why it was recalled
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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