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OrganOx Ltd recalls OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D
Recalled November 27, 2024 · FDA recall Z-0501-2025 · OrganOx
Hazard
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket · FDA Class II
Units
20 units
Sold at
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
Description
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
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.
Manufacturer(s)
OrganOx Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →