XVIVO Organ Chamber REF 19020
Check against the official notice below — it lists the full affected range.
XVIVO Perfusion AB is recalling the XVIVO Organ Chamber (Model Number 19020) due to an incomplete weld seal on the primary pouch that prevents the company from ensuring the product's sterility. A total of 80 devices across six lot numbers (13801-13806) have been affected. The recalled devices were distributed in the United States to California, Florida, Massachusetts, North Carolina, New York, Ohio, Pennsylvania, and Texas, as well as internationally to Austria, Canada, France, Ireland, Italy, and the Netherlands.
The product was manufactured with an incomplete weld seal on the primary pouch, which compromises the sterility assurance required for this medical device. The recall record does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Reason for recall: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. Distribution: U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland Quantity: 80 devices Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.