FDAFDA · Food and drugs·Recall number Z-1053-2024
Bubble Sensor (REF: 70105.5720)
Published February 14, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Medical Systems USA
- Distributor
- AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
- Lot
- 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;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.