FDAFDA · Food and drugs·Recall number Z-2431-2024
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Published July 31, 2024 · Recall initiated: May 22, 2024
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
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical
- Distributor
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom.
- Lot
- All Serial numbers/UDI: 05415067030023 and 05415067020260
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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