The Recall Desk

FDA (Devices) recall action 82426

COVIDIEN LLC recalled 3 products on 2019-05-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-05-01
Critical
0
Units
7,636

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2019-05-01

    Covidien Endo Clinch II Auto Suture Grasper Recalled for Sterilization Issues

    COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper because the sterilization method used was not consistent with the labeling and approved method.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-01

    Covidien Procedure Kits Recalled for Sterilization Labeling Inconsistency

    Covidien LLC is recalling 148 procedure kits because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-01

    Covidien Endo Grasp Auto Suture Grasper Recalled for Sterilization Labeling Error

    COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm because the sterilization method used was not consistent with the labeling and approved method.

    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…
    Category
    Distribution
    0 states