OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D
Summary
The FDA issued a Class II for OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor tran by OrganOx Ltd. Reason: Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket.
Details
Source
Device Recall
External ID
Z-0501-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 20 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-15
Company
Oxford, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OrganOx Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OrganOx Ltd have FDA actions?
This is the only FDA action we have on record for OrganOx Ltd in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0501-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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