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Recall Observatory FDA recall evidence

Device product

Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.

Z-1212-2019

March 13, 2019

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 82426
Status
Terminated
Classification
Class II
Quantity
240 units
Official record key
device-enforcement:Z-1212-2019

Official wording

Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method

Code information: Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX

Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterilization method used was not consistent with the labeling and the approved sterilization method