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 |
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| 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. |
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