NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, re
Summary
The FDA issued a Class II for NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life s by Mc3 Inc. Reason: May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water .
Details
Source
Device Recall
External ID
Z-1309-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
Lot/Code Info: GTIN: (1) 10854916006888; (2) 10854916006901,20854916006908 (New GTIN (USA only)After reboxing). All Serial Numbers between 481022923 and 481024039
Quantity Affected: 299 units
Reason for Recall
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-11
Company
Dexter, MI
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 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mc3 Inc has 3 FDA actions in our database, including 2 recalls and 1 clearance.
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 (Mc3 Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mc3 Inc have FDA actions?
Mc3 Inc has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1309-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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