Reported Jan 15, 2020 · Ongoing

Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the…

Baxter Healthcare Corporation

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: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Clearlink System Continu-Flo Administration Sets
  • Product Codes
    • 2C8519
    • 2C8537
  • and 2C8541 - Product UsageFor the administration of fluids from a container into the patients vascular system through a vascular access device
Lot codes and dates
  • Product Codes
    • 2C8519
    • UDI 00085412048994
    • 2C8537
    • UDI 00085412048970
    • and 2C8541
    • UDI 00085412071107 All Lots
Amount recalled
271,014,984 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

  • Nationwide

Why it was recalled

Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

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

Data as of Sep 19, 5:25 PM UTC

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