XVIVO PERFUSION AB
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- System/Device, Pharmacy CompoundingProduct code NEP (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440
Recalls & enforcement
- Class IITerminated2022-04-08The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
FDA inspections (1)
- NAI2016-02-25No Action Indicated · Project Evaluation: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
- All facilities operated by XVIVO Perfusion AB
- XVIVO BV (NL)
- XVIVO PERFUSION, INC. (CO)
- XVIVO PERFUSION, INC. (CO)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “XVIVO PERFUSION AB (FEI 3007710603) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007710603-xvivo-perfusion-ab/
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