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U.S. Department of Health and Human Services

Class 2 Device Recall 17G Cryoablation Needle Holder

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  Class 2 Device Recall 17G Cryoablation Needle Holder see related information
Date Initiated by Firm April 12, 2012
Date Posted May 16, 2012
Recall Status1 Terminated 3 on August 16, 2012
Recall Number Z-1613-2012
Recall Event ID 61657
510(K)Number K060144  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO.

Product Usage:
Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.
Code Information N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002; N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008; N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003; N7729-004; N7890-001; N7890-002 ; N7975-004;N7975-005
Recalling Firm/
Manufacturer		 Galil Medical, Inc.
4364 Round Lake Rd W
Arden Hills MN 55112
For Additional Information Contact
484-530-3900 Ext. 1354
Manufacturer Reason
for Recall		 Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.
FDA Determined
Cause 2		 Material/Component Contamination
Action Galil Medical sent an "Urgent Medical Device Recall" letter dated April 12, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken. The letter instructs customers to return all unused affected products, use a revised needle preparation procedure and forward and communicate this Recall Notice and instructions. Customers were instructed to complete and return the attached Response Form with returned product or fax to 1+877-510-7757. For any questions contact Galil Medical Customer Service.
Quantity in Commerce 26 kits
Distribution Worldwide Distribution - USA (nationwide) including the states of CA, NY, NC, WA and the countries of CANADA, DENMARK, FRANCE, NETHERLANDS, TAIWAN and UNITED KINGDOM.
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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