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Terminated

Hard shell carry case for the LIFEPAK CR Plus.

FDA Recall Z-0005-06 · Posted 2005-10-04

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2005-07-12
Date Terminated2006-06-26
Product Quantity133 cases

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).

Firm 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.

Root Cause

Process control

Distribution Pattern

Cases were distributed nationwide and internationally.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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