Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
Class I - DangerousWhat Should You Do?
- Check if you have this product: N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X & N8B0993X
- 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 MEDTRONIC
- Reason for Recall:
- Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
Product Codes/Lot Numbers:
N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X & N8B0993X
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2507-2018
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