Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0210-05

Deltec Cozmo Insulin Pump

Abbott Medical / initiated 2004-09-18 / Terminated

Smiths Medical MD, Inc. began a recall of Deltec Cozmo Insulin Pump on . The reason FDA records is "The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0210-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
Deltec Cozmo Insulin Pump
Product code
LZG Pump, Infusion, Insulin
Reason for recall
The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.
FDA root cause
Other
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.
Quantity in commerce
6 pumps to patients and 30 pumps in France
Distribution
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.
Product codes and lots
Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A207742