Reported Sep 2, 2020 · Terminated

Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product…

Klarity Medical Products 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: Klarity Medical Products LLC · 600 Industrial Pkwy · Heath, OH · 43056-1528

Is this the product you have?

    • Klarity Vacuum Bags
    • Item Nos. R7504-30C
    • R7504-35BC
    • R7504-35C
    • R7644-32.5BC
    • RC7221-25BC
    • RC7504-17.5C -
  • Product UsageTo be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting
Lot codes and dates
  • Lots R7504-30C70621Y
  • and 81008X R7504-35BC70415V
  • and 71220V R7504-35C81008W R7644-32.5BC: 71228S
  • RC7221-25BC70502Y and 70621W RC7504-17.5C: 80411A and 80802W
Amount recalled
111 units

Where it was sold

Why it was recalled

Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

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 Oct 19, 2020 · Data as of Sep 19, 5:33 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.