Reported Jun 2, 2021 · Terminated

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment…

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?

  • Gambro Cartridge Blood Set
  • Product Code 101025 - Product Usageintended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems
Lot codes and dates
  • Product Code
    • 101025
    • Lot 1000276191
  • UDI37332414007837
Amount recalled
17,487 units

Why it was recalled

There is a potential leak between the venous patient connector and patient's hemodialysis access.

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 May 10, 2024 · Data as of Sep 19, 5:41 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.