Organ Preservation Device Recalled Due to Incomplete Weld Seal

Plain-English summary

XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020, a medical device designed for organ preservation and perfusion during transplant procedures. Approximately 80 devices are affected across lots 13801 through 13806.

The recall was initiated because the weld seal of the primary pouch was incomplete, which compromises the manufacturer's ability to ensure that the product meets required sterility standards. Sterility assurance is essential for organ preservation devices.

The devices were distributed in the United States in California, Florida, Massachusetts, North Carolina, New York, Ohio, Pennsylvania, and Texas. International distribution included Austria, Canada, France, Ireland, Italy, and the Netherlands.

Facilities or individuals who may have received affected devices should verify whether they have inventory matching the recalled lot numbers. Any affected inventory should not be used, and the recalling firm should be contacted for instructions regarding replacement or corrective action.

The recalled product

Product

XVIVO Organ Chamber REF 19020

Manufacturer

XVIVO PERFUSION AB

Category

Medical Device — Organ Preservation

Hazard

• weld-defect
• contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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