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Recall Observatory FDA recall evidence

Device product

Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

Z-1211-2019

March 13, 2019

Class II

Product summary

Firm
COVIDIEN LLC
Event
Event 82426
Status
Terminated
Classification
Class II
Quantity
7248 units
Official record key
device-enforcement:Z-1211-2019

Official wording

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

Code information: Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX

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