Organ Preservation Device Recalled Due to Incomplete Weld Seal
XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020 due to an incomplete weld seal on the primary pouch that prevents sterility assurance. Approximately 80 devices were distributed in the U.S. and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with an incomplete weld seal that prevents sterility assurance. No illnesses or injuries have been reported; the hazard is theoretical rather than realized.
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
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
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