Z-0004-06

Hard shell carry case for the LIFEPAK 500 AED

Name: Z-0004-06 Hard shell carry case for the LIFEPAK 500 AED
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2005-07-12
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2005-07-12 / Terminated / root cause: manufacturing process

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of Hard shell carry case for the LIFEPAK 500 AED on 2005-07-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0004-06
Status: Terminated
Initiated: 2005-07-12
Posted: 2005-10-04
Terminated: 2006-06-26
Recalling firm: Physio Control, Inc.
Product: Hard shell carry case for the LIFEPAK 500 AED.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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).
Root cause tag: manufacturing process
FDA root 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: 4608 cases
Distribution: Cases were distributed nationwide and internationally.
Product codes and lots: Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002

Product code MKJ

K010918Class IIILifepak 12 Defibrillator/monitor SystemMedtronic Physio-Control Corp. / cleared 2001-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)