SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Class I - DangerousWhat Should You Do?
- Check if you have this product: N6C0533UX N6C0582UX N6C0657UX N6C0681UX N6E0115UX N6E0116UX N6E0976UX N6E0977UX N6E0978UX N6E0979UX N6F0045UX N6F0046UX N6F0047UX N6F0048UX N6F0049UX N6F0050UX N6F0295UX N6F0503UX N6F0504UX N6F0505UX N6F0506UX N6F0507UX N6F0508UX N6F0509UX N6F0748UX N6F0758UX N6F0759UX N6F0760UX N6F0786UX N6F0787UX N6F0788UX N6G0068UX N6G0270UX N6G0271UX N6G0287UX N6G0288UX N6G0486UX N6G0499UX N6G0784UX N6G0785UX N6G0786UX N6H0105UX N6H0106UX N6H0107UX N6H0155UX N6H0156UX N6H0157UX N6H0173UX N6H0174UX N6H0298UX N6H0299UX N6H0302UX N6H0522UX N6H0693UX N6H0734UX N6H0909UX N6H0946UX N6J0040UX N6J0092UX N6K0302UX N6K0970UX N6K1067UX N6L0152UX N6M0328UX N7A0170UX N7C0475X N7C1091X N7C1092X N7D0104X N8A0087X N8D0035X N8D0225X
- 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:
- Covidien LLC
- Reason for Recall:
- The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Product Codes/Lot Numbers:
N6C0533UX N6C0582UX N6C0657UX N6C0681UX N6E0115UX N6E0116UX N6E0976UX N6E0977UX N6E0978UX N6E0979UX N6F0045UX N6F0046UX N6F0047UX N6F0048UX N6F0049UX N6F0050UX N6F0295UX N6F0503UX N6F0504UX N6F0505UX N6F0506UX N6F0507UX N6F0508UX N6F0509UX N6F0748UX N6F0758UX N6F0759UX N6F0760UX N6F0786UX N6F0787UX N6F0788UX N6G0068UX N6G0270UX N6G0271UX N6G0287UX N6G0288UX N6G0486UX N6G0499UX N6G0784UX N6G0785UX N6G0786UX N6H0105UX N6H0106UX N6H0107UX N6H0155UX N6H0156UX N6H0157UX N6H0173UX N6H0174UX N6H0298UX N6H0299UX N6H0302UX N6H0522UX N6H0693UX N6H0734UX N6H0909UX N6H0946UX N6J0040UX N6J0092UX N6K0302UX N6K0970UX N6K1067UX N6L0152UX N6M0328UX N7A0170UX N7C0475X N7C1091X N7C1092X N7D0104X N8A0087X N8D0035X N8D0225X
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1834-2019
Related Recalls
Temperature probe devices lack FDA clearance.
Due to customer complaint regarding incorrect display box labeling.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.