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U.S. Department of Health and Human Services

Class 2 Device Recall Retractor System Elastic Stays

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  Class 2 Device Recall Retractor System Elastic Stays see related information
Date Initiated by Firm September 04, 2018
Create Date September 27, 2018
Recall Status1 Terminated 3 on April 15, 2020
Recall Number Z-3278-2018
Recall Event ID 81037
510(K)Number K791665  
Product Classification Retractor - Product Code GAD
Product Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG)

Product Usage:
The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.
Code Information Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers to do the following: Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you have no affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.
Quantity in Commerce 18,000 units
Distribution Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.
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 = GAD and Original Applicant = LONE STAR MEDICAL PRODUCTS, INC.
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