Recall Z-1212-2022 ยท PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
XVIVO PERFUSION AB
XVIVO Organ Chamber REF 19020
| Date | Apr 8, 2022 |
| Status | Terminated |
| Reason | The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. |
| Root cause | Under Investigation by 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 follo |
| Quantity | 80 devices |
| Distribution | U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.