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U.S. Department of Health and Human Services

Class 2 Device Recall BiPolar Vaporization Electrodes

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  Class 2 Device Recall BiPolar Vaporization Electrodes see related information
Date Initiated by Firm September 18, 2013
Date Posted November 04, 2013
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-0145-2014
Recall Event ID 66457
510(K)Number K062720  
Product Classification Resectoscope - Product Code FJL
Product Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF;

Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF

S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.
Code Information *** Individual Units ***  Product Code: 4630022 (single);  Lot: 426111;  Expiration Date: 2016/06;  *** Cartons ***  Product Code: 46300223 (box of 3);  Lot: 426111;  Expiration Date: 2016/06;  
Recalling Firm/
Manufacturer		 Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information Contact Lisa Williams
800-323-9653 Ext. 225
Manufacturer Reason
for Recall		 Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
FDA Determined
Cause 2		 Process control
Action The firm, Richard Wolf, sent an "Urgent: Medical Device Recall" letter dated September 16, 2013, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory of vaporization electrodes from lot 426111, contact Richard Wolf Medical Instrument Corporation at 800-323-9653 x 344 or ext 225 or ext. 380 to inform Richard Wolf Medical Instrument Corporation if the customer has or does not have any devices from this lot, return the affected devices with the return authorization provided by Richard Wolf Medical Instrument Corporation for credit, and complete and return the attached Recall Response form via fax to: 847-913-0924; email: dclark@richardwolfusa.com; or mailed to: Richard Wolf Medical Instrument Corporation, 353 Corporate Woods Parkway, Vernon Hills, IL 60061-3110. Customers who require urgent replacement of the affected devices can contact their customer service representative for replacement. If you have any questions, call 800-323-9653 x 344.
Quantity in Commerce 78 cartons (234 units)
Distribution Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.
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 = FJL and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.
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