FDAFDA · Food and drugs·Recall number Z-1458-2024
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Published April 10, 2024 · Recall initiated: February 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien, LP
- Distributor
- Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
- Lot
- Model Number: SIGSDS30CTVT; UDI/DI: 10884521741888; Lot numbers: N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, N3M1639UY;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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