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U.S. Department of Health and Human Services

Class 2 Device Recall Ally Uterine Positioning System (Ally UPS)

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  Class 2 Device Recall Ally Uterine Positioning System (Ally UPS) see related information
Date Initiated by Firm May 18, 2015
Date Posted June 08, 2015
Recall Status1 Terminated 3 on August 07, 2015
Recall Number Z-1727-2015
Recall Event ID 71308
510(K)Number K141523  
Product Classification Cannula, manipulator/injector, uterine - Product Code LKF
Product Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators
during gynecological laproscopic procedures
Model: Ally UPS
Code Information Serial Numbers: 020015;020021;020023; 020043;020051
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Nana Banafo
203-601-5200 Ext. 3350
Manufacturer Reason
for Recall		 Design of device may expose user to injury to fingers or body parts
FDA Determined
Cause 2		 Device Design
Action CooperSurgical initiated the recall on May 18, 2015 via Fedex with confirmed delivery receipt. The letter identified the affected product and asked users to discontinue use and complete the Acknowledgement and Receipt Form to schedule a replacement. Questions contact 203.601.5200.
Quantity in Commerce 5 units
Distribution Distributed in the states of CA, IL, NC, and NY.
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 = COOPER SURGICAL, INC.
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