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Terminated

XVIVO Organ Chamber REF 19020

FDA Recall Z-1212-2022 · Posted None

Recalling FirmXVIVO PERFUSION AB
Recall StatusTerminated
Product CodePHO
Date Initiated2022-04-08
Date Terminated2025-01-30
Product Quantity80 devices

Reason for Recall

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

Firm Action

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 [email protected] 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 [email protected] or telephone number +1-303-395-9171.

Root Cause

Under Investigation by firm

Distribution Pattern

U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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