The Recall Desk

FDA (Devices) recall action 77167

Cook Inc. recalled 6 products on 2017-06-14

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2017-06-14
Critical
0
Units
654

Why these products were recalled

COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

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.

1–6 of 6

  • ModerateFDA (Devices)··2017-06-14

    Cook Medical Recalls LapSac Introducers Due to Inadequate Reprocessing Instructions

    Cook Medical is voluntarily recalling LapSac Introducers because the reprocessing instructions do not provide sufficient detailed information for cleaning, disinfection, and sterilization.

    Product
    LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-06-14

    Cook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-06-14

    Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-06-14

    Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies

    Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.

    Product
    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of stand
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Distribution
    0 states