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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 12, 2005
Date Posted October 04, 2005
Recall Status1 Terminated 3 on June 26, 2006
Recall Number Z-0005-06
Recall Event ID 32642
510(K)Number K011194  
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 2
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.
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