Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model 407831, Lot 7748246, GTIN: 15414734008805
- 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:
- As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Product Codes/Lot Numbers:
Model 407831, Lot 7748246, GTIN: 15414734008805
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0420-2022
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Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.