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Terminated

Deltec Cozmo Insulin Pump

FDA Recall Z-0210-05 · Posted 2004-11-19

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-09-18
Date Terminated2005-08-19
Product Quantity6 pumps to patients and 30 pumps in France

Reason for Recall

The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.

Firm Action

All customers were contacted and instructed to only use the Beeper alarm function and not the vibrate alarm feature. Patients were instructed to return the affected pump to Smiths Medical MD upon receipt of the replacement pump.

Root Cause

Other

Distribution Pattern

371 = Number of Individual Product Manufactured 6 = Number of Product Distributed to Patients 365 = Number of Products Either at Smiths Medical MD or at the Distributor or with a Smiths Medical MD Sales Rep.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020655DELTEC INSULIN INFUSION PUMP AND ACCESSORIESDeltec, Inc. · 2002-08-13

Official Source

View FDA Recall →

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

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