Medical device recalls Moderate risk

Cardinal Health Inc. recalls Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients…

Recall date
November 16, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0702-2019
FDA classification
Class II
Brand / firm
Cardinal Health Inc.
Sold / distributed
US state of Florida

Why it was recalled

The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

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