FDAFDA · Food and drugs·Recall number Z-0501-2025
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
Published November 27, 2024 · Recall initiated: October 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- OrganOx Ltd
- Distributor
- California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
- Lot
- UDI-DI: 05060462240029 Serial numbers 511, 512, 514, 515, 516, 517, 518, 519, 520, 522, 523, 524, 525, 527, 528, 529, 530, 531, 533, 535, 536, 537
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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