Product Wiki · Recalls · U.S. FDA — Device Enforcement

XVIVO Organ Chamber REF 19020 — recall Z-1212-2022

U.S. FDA — Device Enforcement · Sweden · 2022-04-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1212-2022
Date of alert
2022-04-08
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
XVIVO PERFUSION AB
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07350069520074
Reported risk: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.