Class 3 Device Recall Philipe Medical

• Date Initiated by Firm: November 18, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on July 12, 2006
• Recall Number: Z-0321-06
• Recall Event ID: 34045
• 510(K)Number: K003228
• Product Classification: Electrode, Electrocardiograph, Multi-Function - Product Code MLN
• Product: HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M3717A
• Code Information: Lot Number : Y042005-1
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3000 Minuteman Road; Andover MA 01810-1032
• For Additional Information Contact: Peter Ohanian; 978-659-4863
• Manufacturer Reason for Recall: The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector
• FDA Determined Cause: Other
• Action: Philips Medical sent the recall notification letter 11/30/05 via FedEx
• Quantity in Commerce: 253 CASES (5/CS)
• Distribution: Nationwide Foreign: Australia, Canada, France, germany, Spain,, Sweden, Switzerland, UK
• 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 = MLN