Edwards Lifesciences Recalls IV Administration Sets for Regulatory Submission
Edwards Lifesciences is recalling 147,350 units of IV Administration Sets because an additional FDA submission is required to support commercialization.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by a regulatory documentation requirement (additional FDA submission) rather than a product defect or safety hazard, fitting the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Edwards Lifesciences, LLC is recalling 147,350 units of Intravascular (IV) Administration Sets. The affected models include 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, and MK2227.
The recall was initiated due to the requirement of an additional FDA submission to support the commercialization (clearance) of the devices. The source text does not indicate that this is a safety recall or that any adverse health consequences have been reported.
The distribution pattern is listed as US. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 147,350
Distribution
Distribution scope not specified by the agency.
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