Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Class I - DangerousWhat Should You Do?
- Check if you have this product: Affected Lot Numbers/Expiration Date: 19101021 /October 2020 19103124 /October 2020 19121604 /December 2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Acutus Medical Inc
- Reason for Recall:
- It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Product Codes/Lot Numbers:
Affected Lot Numbers/Expiration Date: 19101021 /October 2020 19103124 /October 2020 19121604 /December 2020
Distribution:
Distributed in: US, CA, SC, AZ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1769-2020
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