Reported Sep 11, 2024 · Ongoing

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25.…

Fresenius Kabi USA, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Fresenius Kabi USA, LLC · 50 High St Ste 50 · North Andover, MA · 01845-2620

Is this the product you have?

  • LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
  • Product CodeSET-0013-25. for intravenous infusion
Lot codes and dates
  • Product CodeSET-0013-25
  • UDI-DI00811505030054
  • Lot number3010538
Amount recalled
180 cases/4,500 pieces

Where it was sold

Why it was recalled

Stop using this product now

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new infant & baby recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.