FDAFDA · Food and drugs·Recall number Z-0440-2013
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 of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Published December 5, 2012 · Recall initiated: October 31, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cooper Surgical, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.
- Lot
- Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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