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U.S. Department of Health and Human Services

Class 2 Device Recall ELine Cutting Electrode

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  Class 2 Device Recall ELine Cutting Electrode see related information
Date Initiated by Firm May 23, 2019
Date Posted June 13, 2019
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-1957-2019
Recall Event ID 82946
510(K)Number K980302  
Product Classification Hysteroscope (and accessories) - Product Code HIH
Product E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Code Information Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024
Recalling Firm/
Manufacturer		 Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information Contact Michael G. Loiterman
847-913-1113 Ext. 380
Manufacturer Reason
for Recall		 E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
FDA Determined
Cause 2		 Under Investigation by firm
Action Richard Wolf Medical Instruments, Corp. notified customers on 05/23/2019 via "Urgent Safety Information: Recall" letter. Instructions included to examine distribution reports and stock immediately to determine if any affected devices are on hand, quarantine any affected devices, advise customers of the recall if affected devices were further distributed, and scrap all affected devices on site. Customers were also instructed to complete and return the Answer form provided with the notification letter. An updated "Urgent Safety Information: Recall" letter was sent via email on 06/07/2019 to customers. The letter contained an update to include the hazard and risk. Instructions to customers remained the same as in the original letter.
Quantity in Commerce 5 boxes (5 electrodes each)
Distribution US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
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 = HIH and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.
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