The Recall Desk

FDA (Devices) recall action 63681

Cooper Surgical, Inc. recalled 2 products on 2012-12-05

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-12-05
Critical
0
Units
2,430

Why these products were recalled

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

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.

1–2 of 2

  • SevereFDA (Devices)··2012-12-05

    Cooper Surgical RUMI Arch Uterine Manipulator Handle Recalled for Steel Rod Protrusion

    Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.

    Product
    Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surg
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-12-05

    Cooper Surgical Recalls Advincula Arch Uterine Manipulator Handles

    Cooper Surgical is recalling Advincula Arch handles because the internal steel rod may protrude through the shaft, posing a risk of injury during surgery.

    Product
    Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types
    Category
    Distribution
    0 states