Reported May 22, 2024 · Ongoing

namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT,…

MEDLINE INDUSTRIES, LP - Northfield

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: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

17 of 17 products

Products covered by this recall
Model / numberProduct as published
60011045CAROTID MANIFOLD KIT
600705823V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT
60071822LEFT HEART KIT
60080085LEFT HEART KIT
60100055CONVENIENCE KIT
60101041CONVENIENCE KIT
60120336CONVENIENCE KIT
60131446LEFT HEART KIT
601407983 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION
60142592CONVENIENCE KIT
60183972LEFT HEART KIT
60210209FOUR VALVE MANIFOLD KIT
60210862RIGHT HEART KIT
600705710LEFT HEART KIT
600803410CONVENIENCE KIT
601322913TUBING KIT
60032582ALEFT HEART KIT
Lot codes and dates
  • a) UDI/DI 10193489040456
  • Lot Numbers
    • 0000113192
    • b) UDI/DI 10193489044195
  • Lot Numbers
    • 0000113331
    • c) UDI/DI 10193489044386
  • Lot Numbers
    • 0000112999
    • d) UDI/DI 10193489044416
  • Lot Numbers
    • 0000113000
    • d) UDI/DI 10193489044935
  • Lot Numbers0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI
Amount recalled
570 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

Products have a lack of sterility assurance.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 6:18 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.