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U.S. Department of Health and Human Services

Class 2 Device Recall Cooper Surgical RUMI Arch

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  Class 2 Device Recall Cooper Surgical RUMI Arch see related information
Date Initiated by Firm October 31, 2012
Date Posted November 26, 2012
Recall Status1 Terminated 3 on March 04, 2014
Recall Number Z-0439-2013
Recall Event ID 63681
510(K)Number K932115  
Product Classification Cannula, manipulator/injector, uterine - Product Code LKF
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 surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Cooper Surgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action CooperSurgical issued notification on October 31, 2012, to all affected customers Fed X . The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return units for replacement. Customers with questions should contact Customer Serivce at 1-203-601-9818 or 800-243-2974. Customers were asked to fill out the attached Replacement of Recalled Product Form and fax it to 1-800-262-0105. For questions regarding this recall call 203-601-9818.
Quantity in Commerce 1215 total
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LKF and Original Applicant = BLAIRDEN PRECISION INSTRUMENTS, INC.
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