Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical FASTCATH Hemostasis Introducer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall St. Jude Medical FASTCATH Hemostasis Introducersee related information
Date Initiated by FirmAugust 17, 2009
Date PostedSeptember 18, 2009
Recall Status1 Terminated 3 on December 17, 2011
Recall NumberZ-2228-2009
Recall Event ID 53121
510(K)NumberK791129 
Product Classification Wire, guide, catheter - Product Code DQX
ProductSt. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, 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: 6372
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
ActionField 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 Commerce2,000
DistributionWorldwide Distribution -- US (CA, MI, PA and TN), China and 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 = DQX
-
-