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Recall Observatory FDA recall evidence

Device product

EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

Z-1827-2019

May 17, 2019

Class II

Product summary

Firm
Covidien LLC
Event
Event 82950
Status
Ongoing
Classification
Class II
Quantity
3,113,280
Official record key
device-enforcement:Z-1827-2019

Official wording

Reason: 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.

Code information: N6B0080KX N6C0975KX

Distribution pattern: Nationwide domestic distribution, worldwide foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.