Z-1212-2022Class II

XVIVO Organ Chamber REF 19020

Name: Z-1212-2022 XVIVO Organ Chamber REF 19020
Creator: Xvivo Perfusion Ab
Published: 2022-04-08
License: https://open.fda.gov/license/

Xvivo Perfusion, Inc. / initiated 2022-04-08 / Terminated / root cause: packaging

FDA source

XVIVO PERFUSION AB began a recall of XVIVO Organ Chamber REF 19020 on 2022-04-08. FDA classified it as Class II and gives the reason as "The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1212-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-08
Posted: 2022-06-01
Terminated: 2025-01-30
Recalling firm: Xvivo Perfusion, Inc.
Product: XVIVO Organ Chamber REF 19020
Product code: PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Reason for recall: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Root cause tag: packaging
FDA root cause: 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 [email protected] 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1212-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1212-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-08	2022-06-01

Product code PHO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)