Summary
The FDA issued a Class II for Bubble Sensor (REF: 70105.5720) by Maquet Medical Systems USA. Reason: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided .
Details
Source
Device Recall
External ID
Z-1053-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Bubble Sensor (REF: 70105.5720)
Lot/Code Info: Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148; SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097;
Quantity Affected: 274 units (70 US, 204 OUS)
Reason for Recall
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Distribution
AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-28
Company
Wayne, NJ
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 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls.
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 (Maquet Medical Systems USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Medical Systems USA have FDA actions?
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1053-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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