Medical Device Recall: Z-0005-06

FDA Recalls dataset · Firm: Medtronic Emergency Response Systems, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-07-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-06.

Recall Res Number
Z-0005-06
Recalling Firm / Manufacturer
Medtronic Emergency Response Systems, Inc.
FEI Number
3015876
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-07-12
Date Posted
2005-10-04
Date Terminated
2006-06-26
Product Code
MKJ
Event Number
32642
Product Quantity
133 cases
Product Description Hard shell carry case for the LIFEPAK CR Plus.
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).
Action Details 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.
Distribution Pattern Cases were distributed nationwide and internationally.
Code Information / Serial Numbers Cases do not contain serial numbers or lot numbers. Catalog number 3201582-000 through -002.

Related Establishments / Registrations

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