FDA Medical Device Recalls (openFDA)
XVIVO PERFUSION AB: XVIVO Organ Chamber REF 19020
- Recall number
- Z-1212-2022
- Recalling firm
- XVIVO PERFUSION AB
- Product
- XVIVO Organ Chamber REF 19020
- Status
- Terminated
- Initiated
- 2022-04-08
- Posted
- not on file
- Terminated
- 2025-01-30
- Reason
- The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
- 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 customersupport@xvivogroup.com 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 customersupport@xvivogroup.com or telephone number +1-303-395-9171.
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P180014"]
- Product code
- PHO
- Firm FEI
- 3007710603
- Firm city
- Goteborg
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28