Z-0439-2013 Class II Terminated
FDA device recall Z-0439-2013 was initiated by Cooper Surgical, Inc. on October 31, 2012 and is designated Class II. 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 recall status is terminated (terminated March 4, 2014). Affected quantity: 1215 total.
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2012
- Initiation Date
- October 31, 2012
- Termination Date
- March 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1215 total
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
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
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.
Code Information
All serial numbers