Class 2 Device Recall Medamicus FlowGuard

• Date Initiated by Firm: June 06, 2003
• Date Posted: July 02, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-0967-03
• Recall Event ID: 26475
• 510(K)Number: K021044
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: Medamicus FlowGuard 16 FR Valved Peelable Venous Introducer, 5 units per shelf box, Part Number 10684-003
• Code Information: Lot Number W24369
• Recalling Firm/ Manufacturer: MedAmicus,Inc; 15301 Highway 55 West; Plymouth MN 55447
• For Additional Information Contact: Karyl Haskell; 763-577-2257
• Manufacturer Reason for Recall: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
• FDA Determined Cause: Other
• Action: The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
• Quantity in Commerce: 11 boxes
• Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
• 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 and Original Applicant = WOLFE TORY MEDICAL, INC.