Class 2 Device Recall Deltec Ventra

• Date Initiated by Firm: July 08, 2003
• Date Posted: July 30, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-1067-03
• Recall Event ID: 26715
• 510(K)Number: K904334
• Product Classification: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
• Product: Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106
• Code Information: Lot numbers M20690, 95310
• Recalling Firm/ Manufacturer: Deltec, Inc; 1265 Grey Fox Road; St Paul MN 55112
• For Additional Information Contact: Michael Herbert; 651-628-7049
• Manufacturer Reason for Recall: Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
• FDA Determined Cause: Other
• Action: A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.
• Distribution: The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
• 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 = FOZ and Original Applicant = PHARMACIA DELTEC, INC.