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U.S. Department of Health and Human Services

Class 2 Device Recall Urethral Warmer System

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  Class 2 Device Recall Urethral Warmer System see related information
Date Initiated by Firm November 11, 2010
Date Posted December 29, 2010
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-0832-2011
Recall Event ID 57254
510(K)Number K010991  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product Urethral Warmer System Model number FPRCH3001
The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
Code Information GW469, GW470, GW468, GW472
Recalling Firm/
Manufacturer		 Galil Medical
4364 Round Lake Road
Arden Hills MN 55112
For Additional Information Contact
651-530-3900
Manufacturer Reason
for Recall		 This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Gali
FDA Determined
Cause 2		 Other
Action Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to: " Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. " Immediately discontinue use and quarantine the affected product. " Contact Customer Service Department at 800-828-7341 to arrange for replacement. " Complete the attached form for each unit and follow the instructions given to return the form by fax or e-mail. " If customers further distributed the product to another person or entity, they were to identify their customers and notify them at once of this product recall by including a copy of the recall notification letter and the attached form. For questions regarding this recall call 800-828-7341 or 716-662-2551.
Quantity in Commerce 4
Distribution Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
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 = GEH and Original Applicant = GALIL MEDICAL LTD.
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