XVIVO PERFUSION AB: Medical Device Recall in 2022 - (Recall #: Z-1212-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

XVIVO Organ Chamber REF 19020

Product Classification:

Class II

Date Initiated: April 8, 2022

Date Posted: June 8, 2022

Recall Number: Z-1212-2022

Event ID: 90143

Reason for Recall:

The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Status: Terminated

Product Quantity: 80 devices

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

Distribution Pattern:

U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland

Voluntary or Mandated:

Voluntary: Firm initiated