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U.S. Department of Health and Human Services

Class 2 Device Recall Cooper Surgical Advincula Arch

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 Class 2 Recall
Cooper Surgical Advincula Arch
see related information
Date Posted November 26, 2012
Recall Status1 Terminated on March 04, 2014
Recall Number Z-0440-2013
Recall Event ID 63681
Premarket Notification
510(K) Number
K932115 
Product Classification Cannula, Manipulator/Injector, Uterine - Product Code LKF
Product 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
Code Information Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
Recalling Firm/
Manufacturer
Cooper Surgical, Inc.
95 Corporate Dr
Trumbull, Connecticut 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LKF and Original Applicant = BLAIRDEN PRECISION INSTRUMENTS, INC.
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