Reported Jun 24, 2020 · Terminated

Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only…

Resource Optimization & Innovation 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: Resource Optimization & Innovation LLC · 645 Maryville Centre Dr Ste 200 · Saint Louis, MO · 63141-5846

Is this the product you have?

  • Regard SRHS Central Line Kit, Sterile, 20/case -
  • Product UsageThe Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices
Lot codes and dates
  • Item number 303399REGlot
  • numbers
    • 257967
    • 259035
    • 260742
    • 259418
    • 261252
    • 261888
    • 263836
    • 264669
    • 268918
    • 271005
    • 265730
    • 270198
    • and 270567
Amount recalled
12,640 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

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 Sep 23, 2022 · Data as of Sep 19, 4:49 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.