FDAFDA · Food and drugs·Recall number Z-1835-2019
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
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
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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