Infusion pump administration sets recalled over incorrect assembly of one lot
Fresenius Kabi USA is recalling 483 cases of Ivenix LVP Primary Administration Sets after incorrect assembly of a specific lot that the firm states could result in serious patient injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The IVENIX INFUSION SYSTEM LVP Primary Administration Set, dual-inlet, low-sorbing, needle-free port, dual Y-site, supplied 25 per case, is being recalled by Fresenius Kabi USA. The product is a large volume infusion pump administration set.
The recall follows incorrect assembly of a specific lot of the LVP Primary Administration Set that the firm states could result in serious patient injury.
The recall covers 483 cases, listed as 12,075 eaches, under product code SET-0032-25 and UDI 00811505030214, from lot FA25B03126. Distribution was nationwide in the United States, in Illinois, Maryland, Michigan, Oklahoma, South Carolina, Texas, Virginia and Wisconsin. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine the affected lot immediately and follow Fresenius Kabi's instructions.
The recalled product
- Product
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion set
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code: SET-0032-25
- UDI: 00811505030214
- Lot No. FA25B03126.
Distribution
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