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
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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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