XVIVO PERFUSION AB Massans Gata 10 Goteborg Sweden XVIVO Organ Chamber REF 19020 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Recommended Action

Per FDA guidance

On or about 04/11/2022, XVIVO Inc. issued an "URGENT- Field Safety Notice" for its XVIVO Organ Chamber via email to customers informing them XVIVO has identified that the primary package for a number of batches may have notable defects in the weld of the bag. The notable defects are unsealed sections of the weld (i.e. the bag is not completely closed). Unsealed sections in the weld may compromise the sterility of the product and therefore it is important to NOT use a product showing this defect. Customer are instructed to: 1. Carefully check the primary package for unsealed sections. A follow-up "URGENT:-Medical Device Correction" issued on or about 05/06/2022, this letter provides photos of example of unsealed welds. 2. If unsealed sections are noted, do not use the product and contact XVIVO Customer Support at customersupport@xvivogroup.com for further action. 3. if not defects are noted, the product may be used as intended. Any questions or additional information, contact Customer Support at customersupport@xvivogroup.com or telephone number +1-303-395-9171.

Distribution

As reported by FDA

CA, FL, MA, NY, NC, OH, PA, TX