Class 2 Device Recall Delphi IVantage

• Date Initiated by Firm: March 29, 2006
• Date Posted: August 26, 2006
• Recall Status: Terminated on October 16, 2006
• Recall Number: Z-1445-06
• Recall Event ID: 35121
• 510(K)Number: K953896
• Product Classification: Infusion pump - Product Code FRN
• Product: Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Delphi Medical Systems; 5725 Delphi Dr; Troy MI 48098-2815
• For Additional Information Contact: 248-813-2379
• Manufacturer Reason for Recall: Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
• FDA Determined Cause: Other
• Action: Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.
• Quantity in Commerce: 22 US and 147 international.
• Distribution: Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.
• 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 = FRN and Original Applicant = IMED CORP.