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U.S. Department of Health and Human Services

Class 2 Device Recall Galil Medical Warming Catheter

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  Class 2 Device Recall Galil Medical Warming Catheter see related information
Date Initiated by Firm December 11, 2007
Date Posted September 03, 2008
Recall Status1 Terminated 3 on September 02, 2008
Recall Number Z-1698-2008
Recall Event ID 47888
510(K)Number K012497  
Product Classification Urethral Warming Catheter - Product Code GEH
Product Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue.
Code Information Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003.
Recalling Firm/
Galil Medical
401 Plymouth Rd Ste 130
Plymouth Meeting PA 19462-1651
Manufacturer Reason
for Recall
The warming catheter was manufactured with the inlet and outlet tubes switched.
FDA Determined
Cause 2
Process control
Action The recalling firm telephoned their customers in April 2008 to inform them of the problem and the need to return the product. There customers were also asked to contact the firm if they had actually used any of the kits with the serial numbers listed, even if they experienced no problem. As a follow up to the telephone call, a letter was issued to the customers. For assistance, please call 770-565-6166.
Quantity in Commerce 541 catheters
Distribution Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and 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.