Amplatzer Steerable Delivery Sheath
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741
- 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:
- Abbott
- Reason for Recall:
- Instructions for use were updated.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Amplatzer Steerable Delivery Sheath
Product Codes/Lot Numbers:
Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0895-2022
Related Recalls
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.