Class 2 Device Recall

• Date Initiated by Firm: July 12, 2005
• Date Posted: October 04, 2005
• Recall Status: Terminated on June 26, 2006
• Recall Number: Z-0005-06
• Recall Event ID: 32642
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: Hard shell carry case for the LIFEPAK CR Plus.
• Code Information: Cases do not contain serial numbers or lot numbers. Catalog number 3201582-000 through -002.
• Recalling Firm/ Manufacturer: Medtronic Emergency Response Systems, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: John A. Parks; 425-867-4681
• Manufacturer Reason for Recall: Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
• FDA Determined Cause: Process control
• Action: On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.
• Quantity in Commerce: 133 cases
• Distribution: Cases were distributed nationwide and internationally.
• 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.