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U.S. Department of Health and Human Services

Class 2 Device Recall XPS" With Steen Solution" Perfusate

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  Class 2 Device Recall XPS" With Steen Solution" Perfusate see related information
Date Initiated by Firm April 08, 2022
Create Date June 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1212-2022
Recall Event ID 90143
PMA Number P180014 
Product Classification Normothermic preservation system for transplantation of initially unacceptable donor lungs - Product Code PHO
Product XVIVO Organ Chamber REF 19020
Code Information Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806 
Recalling Firm/
Manufacturer		 XVIVO PERFUSION AB
Massans Gata 10
Goteborg Sweden
Manufacturer Reason
for Recall		 The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = PHO and Original Applicant = XVIVO Perfusion, Inc.
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