Class 2 Device Recall Disposable TearAway Introducer Sets

• Date Initiated by Firm: June 06, 2005
• Date Posted: October 21, 2005
• Recall Status: Terminated on October 10, 2006
• Recall Number: Z-0065-06
• Recall Event ID: 32667
• Product Classification: Endoscope, Neurological - Product Code GWG
• Product: Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.
• Code Information: Lot No. 040508, 041111, 042116, 042367, 043146, 050077, 041464
• Recalling Firm/ Manufacturer: Remington Medical Inc.; 6830 Meadowridge Ct; Alpharetta GA 30005-2202
• For Additional Information Contact: Maria Granito; 800-989-0057
• Manufacturer Reason for Recall: The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
• FDA Determined Cause: Other
• Action: A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.
• Quantity in Commerce: 3180 units
• Distribution: AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI
• 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.