Abbott Infinity 7 recall: Labeling Error
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Why was Abbott Infinity 7 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Serial numbers/UDI: 05415067020277
- Product
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
- Recalling firm
- Abbott Medical
- Quantity
- 1198 units
- Distribution
- 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.
- Recall date
- July 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)