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U.S. Department of Health and Human Services

Class 2 Device Recall Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter

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 Class 2 Device Recall Response Fixed Curve DECA 6F 65cm CSL 2/8 Cathetersee related information
Date Initiated by FirmOctober 14, 2014
Date PostedNovember 06, 2014
Recall Status1 Terminated 3 on December 10, 2014
Recall NumberZ-0177-2015
Recall Event ID 69512
510(K)NumberK894500 
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
ProductSt. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Code Information Batch # 4671318
Recalling Firm/
Manufacturer		 St Jude Medical
1 Saint Jude Medical Dr
Saint Paul MN 55117-1789
For Additional Information ContactRachel Ellingson
651-756-2295
Manufacturer Reason
for Recall		St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
FDA Determined
Cause 2		Labeling mix-ups
ActionSt. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
Quantity in Commerce26
DistributionUS Distribution including the states of CA, GA, NJ, NY, OR and PA.
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 = DRF
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