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Recall Observatory FDA recall evidence

Device product

EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

Z-1825-2019

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-1825-2019

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: lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX

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.