FDA recall Z-0501-2025

OrganOx Ltd · Class II · device

Product

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.

Reason for recall

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Distribution

California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.

Key facts

Status
Ongoing
Initiation date
2024-10-15
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oxford, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2025