Class 2 Device Recall FastCath Trio" Hemostasis Introducer

• Date Initiated by Firm: October 14, 2014
• Date Posted: October 22, 2014
• Recall Status: Terminated on March 25, 2015
• Recall Number: Z-0108-2015
• Recall Event ID: 69499
• 510(K)Number: K954317
• Product Classification: Introducer, catheter - Product Code DYB
• Product: St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.
• Code Information: Batch 4641580
• FEI Number: 3007562768
• Recalling Firm/ Manufacturer: St Jude Medical; 1 Saint Jude Medical Dr; Saint Paul MN 55117-1789
• For Additional Information Contact: Rachel Ellingson; 651-756-2295
• Manufacturer Reason for Recall: St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
• FDA Determined Cause: Process control
• Action: St. Jude Medical sent an Urgent Medical Device Recall Notice dated October 14, 2014, to all affected consignees. The letter described the problem and the product affected by the recall. Advised consignees to discontinue us of the device. A St. Jude Medical sales representative were to contact the consignee in the near future to facilitate removal and reconciliation of the recalled device. Customers with questions were instructed to contact their St. Jude Medical sales Representative. For questions regarding this recall call 651-756-2295.
• Quantity in Commerce: 220
• Distribution: Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
• 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 = DYB