SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Class I - DangerousWhat Should You Do?
- Check if you have this product: N6E0296UX N6J1034UX N6J1035UX N6J1036UX N6L0007UX N6L0365UX N6L0721UX N6M0608UX N7A0414UX N7A0844UX N7B0401UX N7C0194X N7E0781X N7F0551X N7F1021X N7F1125X N7H0540X N7H1065X N7K0033X N7K0564X N7L0401X N7M0203X N7M0759X N8A0152X N8A0404X N8A0977X N8B0943X N8C0165X N8C0854X N8D0508X N8D1062X N8E0561X N8E0932X N8E0989X N8E1006X N8E1009X N8E1028X N8J0178X N8M0424Y N8M0530Y N8M0531Y
- 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 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Product Codes/Lot Numbers:
N6E0296UX N6J1034UX N6J1035UX N6J1036UX N6L0007UX N6L0365UX N6L0721UX N6M0608UX N7A0414UX N7A0844UX N7B0401UX N7C0194X N7E0781X N7F0551X N7F1021X N7F1125X N7H0540X N7H1065X N7K0033X N7K0564X N7L0401X N7M0203X N7M0759X N8A0152X N8A0404X N8A0977X N8B0943X N8C0165X N8C0854X N8D0508X N8D1062X N8E0561X N8E0932X N8E0989X N8E1006X N8E1009X N8E1028X N8J0178X N8M0424Y N8M0530Y N8M0531Y
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1835-2019
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