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U.S. Department of Health and Human Services

Class 2 Device Recall Epicor LP Connecting Cable, CC6LPCE

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 Class 2 Device Recall Epicor LP Connecting Cable, CC6LPCEsee related information
Date Initiated by FirmDecember 09, 2008
Date PostedJanuary 30, 2009
Recall Status1 Terminated 3 on December 28, 2010
Recall NumberZ-0946-2009
Recall Event ID 50521
510(K)NumberK080292 
Product Classification Electrosurgical cutting and coagulation device - Product Code OCL
ProductEpicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
Code Information All serial numbers affected, lot numbers 08051201, 08051504, 08052202, 08062605, 08070702, 08070704, 08071604, 08071801, 08072505, 08072506, 08080119, 08080801, 08082702, 08091112, 08092210, 08092608, 08100202, 08100703, 08101005, 08102006, 08102325, 08102805, 08110530, and 08111412.  ***UPDATE 01/09/2009*** Serial numbers NS-10156, NS-10158, NS-10159, NS-10160 and NS-10161 were originally not included in the original submission. The lot number assigned to prior SN assignment adds 08052901, 08081801, 08091801, 08040701, 08071806, 08101326, and 08103001
Recalling Firm/
Manufacturer		 St. Jude Medical Inc
240 Santa Ana Ct
Sunnyvale CA 94085-4512
For Additional Information Contact
408-733-6500 Ext. 301
Manufacturer Reason
for Recall		Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
FDA Determined
Cause 2		Other
ActionThe firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.
Quantity in Commerce158 units distributed.
DistributionWorldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OCL
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