XVIVO Organ Chamber recall: Sterility Concern
XVIVO Organ Chamber REF 19020
Why was XVIVO Organ Chamber recalled?
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- XVIVO Organ Chamber REF 19020
- Recalling firm
- XVIVO PERFUSION AB
- 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
- Recall date
- June 8, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)