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U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical FASTCATH Hemostasis Introducer

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  Class 2 Device Recall St. Jude Medical FASTCATH Hemostasis Introducer see related information
Date Initiated by Firm August 17, 2009
Date Posted September 18, 2009
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2229-2009
Recall Event ID 53121
510(K)Number K791129  
Product Classification Wire, guide, catheter - Product Code DQX
Product St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO.

Used for the introduction of catheters into a vessel.

Code Information Lot Number: 4219
Recalling Firm/
Manufacturer
St. Jude Medical
14901 DeVeau Place
Minnetonka MN 55345
For Additional Information Contact
952-933-4700
Manufacturer Reason
for Recall
St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
FDA Determined
Cause 2
Error in labeling
Action Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm. Contact your local St Jude Medical representative for further information.
Quantity in Commerce 490
Distribution Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
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 = DQX and Original Applicant = DAIG CORP.
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