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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description 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 surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Recall Number Z-0439-2013
Classification Class II
Code Info All serial numbers
Product Distributed Qty 1215 total
Reason For Recall 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

Event Detail

Event Id 63681
Product Type Devices
Status Ongoing
Recalling Firm Cooper Surgical, Inc.
City Trumbull
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.