Reported Jul 13, 2022 · Ongoing

Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and…

Covidien 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: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

  • Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Lot codes and dates
  • 281 of 281 codes

    • Code Information organized as "Model No
    • Serial No
    • GTIN": 8888119369
    • 2009300138
    • 10884521012875
    • 8888119369
    • 1935100070
    • 20884521012872
    • 8888119369
    • 2009300138
    • 20884521012872
    • 8888119369
    • 2026000146
    • 20884521012872
    • 8888119369
    • 2028200160
    • 20884521012872
    • 8888123409
    • 2000700062
    • 10884521012967
    • 8888123409
    • 2000700062
    • 20884521012964
    • 8888123409
    • 2001400081
    • 20884521012964
    • 8888123409
    • 2009400112
    • 20884521012964
    • 8888128459
    • 2127200434
    • 10884521013049
    • 8888128459
    • 2127200434
    • 20884521013046
    • 8888133509
    • 2026000147
    • 20884521013114
    • 8888145048
    • 2005600027
    • 10884521013278
    • 8888145048
    • 2009400106
    • 10884521013278
    • 8888145048
    • 2012100182
    • 10884521013278
    • 8888145048
    • 2012100188
    • 10884521013278
    • 8888145048
    • 2014900141
    • 10884521013278
    • 8888145048
    • 2028200161
    • 10884521013278
    • 8888145048
    • 2028200170
    • 10884521013278
    • 8888145048
Amount recalled
13,526 units

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

Stop using this product now

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

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

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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, 4:11 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.