Reported Jul 31, 2019 · Terminated

Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a…

InfuTronix 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: InfuTronix LLC · 177 Pine St · Natick, MA · 01760-1331

Is this the product you have?

    • Nimbus Administration Set
    • REF HS-004
    • UDI # 00817170020031
  • Product UsageAdminister fluids/medication from a container to a patient through a needle or a catheter
Lot codes and dates
    • 1) Lot # 1805002
    • Exp Date 06/10/2021
    • 2) Lot # 1712005
    • Exp Date 12/19/2020
    • 3) Lot # 1710012
    • Exp Date 10/22/2020
    • 4) Lot # 1901003
    • Exp Date 01/07/2022
Amount recalled
10,800 units

Where it was sold

Why it was recalled

Potential for tube leakage

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 22, 2020 · Data as of Sep 19, 6:17 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.