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U.S. Department of Health and Human Services

Class 2 Device Recall Mederi Stretta Catheter and Accessory Kit

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  Class 2 Device Recall Mederi Stretta Catheter and Accessory Kit see related information
Date Initiated by Firm April 03, 2017
Create Date May 08, 2017
Recall Status1 Terminated 3 on October 10, 2017
Recall Number Z-2050-2017
Recall Event ID 76972
510(K)Number K152317  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Mederi Stretta Catheter and Accessory Kit, Sterile
For Use with the MEDERI MDRF1 GENERATOR ONLY.
Used in the treatment of gastroesophageal reflux disease (GERD).

REF 175-5580
Code Information Lot Numbers:  291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 139ST-16-1 139ST-16-2 139ST-16-3 144ST-16 209ST-16 227ST-16 243ST-16 276ST-15 286ST-16 290ST-16 291ST-16 299ST-16 306ST-16 310ST-15 
Recalling Firm/
Manufacturer		 Mederi Therapeutics, Inc
800 Connecticut Ave Ste 1E01
Norwalk CT 06854-1628
For Additional Information Contact
203-930-9900
Manufacturer Reason
for Recall		 Product sterility compromised due to breach in sterile barrier package
FDA Determined
Cause 2		 Package design/selection
Action Mederi issued initial recall on March 29, 2017, and on April 3, 2017, with a corrected recall letter requesting users identify product and set aside for an inspection by Mederi personnel. Once the inspection is completed return the Acknowledgement Form Customer Service, return via eFax at 888-215-9883, or email to customerservice@mederi-inc.com. Mederi will provide FedEx labels and ensure appropriate packaging for the return. For further questions, please call (203) 930-9900.
Quantity in Commerce 1458 units
Distribution Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.
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 = GEI and Original Applicant = MEDERI THERAPEUTICS INC.
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