FDAFDA · Food and drugs·Recall number Z-1827-2019
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Published June 26, 2019 · Recall initiated: May 17, 2019
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- Nationwide domestic distribution, worldwide foreign distribution.
- Lot
- N6B0080KX N6C0975KX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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