Reported Apr 4, 2018 · Terminated

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

Getinge US Sales 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: GETINGE US SALES LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Lot codes and dates
  • UDI code00384401017899
  • Catalog numberM002000195140
  • Lot number16M21
  • Serial number1092238229
Amount recalled
1

Where it was sold

Why it was recalled

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

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 Jul 3, 2018 · Data as of Sep 19, 4:49 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.