DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 8170368 and 8180673
- 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:
- Dufner Instrumente GmbH
- Reason for Recall:
- Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
Product Codes/Lot Numbers:
Lot Numbers: 8170368 and 8180673
Distribution:
Distributed in: IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2534-2020