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U.S. Department of Health and Human Services

Class 2 Device Recall US Endoscopy

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  Class 2 Device Recall US Endoscopy see related information
Date Initiated by Firm February 04, 2019
Create Date March 13, 2019
Recall Status1 Terminated 3 on August 03, 2020
Recall Number Z-1011-2019
Recall Event ID 82142
510(K)Number K120814  
Product Classification Hemostatic metal clip for the GI tract - Product Code PKL
Product US Endoscopy Padlock Clip defect closure system
Ref: C910001

The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Code Information Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
Manufacturer Reason
for Recall		 Potential esophageal laceration during a patient procedure
FDA Determined
Cause 2		 Device Design
Action The firm, US Endoscopy issued a Recall Notification Letter entitled "URGENT VOLUNTARY RECALL NOTICE" and dated 2/1/19 on 2/4/19 to Customers who purchased affected lots of the Padlock Defect closure system. The Recall Notification Letter was sent to domestic Customers via FedEx with delivery confirmation receipt. Affected international distributors issued Recall Notification Letter via email. Letter identifies the product, problem, and actions to take. The customer were instructed to do the following: 1. Quarantine affected Padlock Clip defect closure systems (C910001 ). 2. Complete the Medical Device Recall Response Card included with this Customer Notification Letter. Your US Endoscopy Product Specialist can assist should you have any questions while completing the Card. 3. Return the completed Medical Device Recall Response Card via email to: orders@usendoscopy.com or via fax to 440-639-4495. If you have any questions regarding this matter, please call: 440-392-7633.
Quantity in Commerce 483 units ( 325 units US and 158 OUS)
Distribution Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
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 = PKL and Original Applicant = APONOS MEDICAL CORP.
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