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U.S. Department of Health and Human Services

Class 3 Device Recall Roth Net Polyp Retrieval

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  Class 3 Device Recall Roth Net Polyp Retrieval see related information
Date Initiated by Firm December 13, 2016
Date Posted March 08, 2017
Recall Status1 Terminated 3 on June 13, 2017
Recall Number Z-1416-2017
Recall Event ID 76153
510(K)Number K122462  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Roth Net Polyp Retrieval
Code Information Model # 0071151; Lot #s: 1613898, Exp. Date October 5, 2019; Lot # 1616337, Exp. Date October 7, 2019; Lot # 1616733, Exp. Date October 7, 2019; Lot # 1616734, Exp. Date October 20, 2019 & Lot # 1616735, Exp. Date October 28, 2019.
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Mrs. Kia (NMI) Pennington
440-358-6055
Manufacturer Reason
for Recall		 The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
FDA Determined
Cause 2		 Labeling mix-ups
Action US Endoscopy Group sent an Urgent: Roth Net Polyp Retriever Recall letter dated January 6, 2017, to all affected customers. The firm requested their customers to do the following: 1. Quarantine and destroy the affected Roth Net devices in your inventory. 2. Contact US Endoscopy Customer Service at 1-800-769-8226 to obtain no cost replacement product. 3. Complete and return the attached Response Card. For further information please call (440) 358-6055.
Quantity in Commerce 2,131 units
Distribution US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.
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 = GCJ and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.
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