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Recall Observatory FDA recall evidence

Device product

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND

Z-1264-2020

January 17, 2020

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 84811
Status
Terminated
Classification
Class II
Quantity
2,180 units
Official record key
device-enforcement:Z-1264-2020

Official wording

Reason: Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

Code information: Lot Number: P9E0022Y

Distribution pattern: US Nationwide, Israel, and Japan

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier to be compromised. Products with a compromised