Quanta System Sterile Optical Laser Fiber, single use
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014
- 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:
- Quanta System, S.p.A.
- Reason for Recall:
- Product sterility is potentially compromised.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Quanta System Sterile Optical Laser Fiber, single use
Product Codes/Lot Numbers:
Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1843-2021
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Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.