Ellen
03-10-2008, 11:19 PM
Go to the link to see the serial numbers
http://www.cozmore.com/news/
March 2008
St. Paul, Minnesota, March 10, 2008 - Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers of the Deltec CozmoŽ Insulin Pump.
Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers (see below) of the Deltec CozmoŽ Insulin Pump.
Only 1023 recently manufactured pumps have been affected by this recall. These pumps were manufactured between November 2007 and January 2008. We have only been notified of 2 occurrences by customers, none of which have required any medical intervention
The reason for this recall is that the pumps may have an issue that affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user. Smiths Medical will be replacing all affected pumps.
After conducting a thorough investigation, Smiths Medical has concluded that the root cause of the motor issue was a manufacturing error with its component supplier. Through process control and process validation, this issue has now been corrected.
We will be notifying customers by mailing the recall letter via regular US Post and by telephoning customers. The Food and Drug Administration (FDA) has been informed of this action.
Any customer inquires related to this action should be addressed to Smiths Medical's customer service center at 1-800-826-9703.
http://www.cozmore.com/news/
March 2008
St. Paul, Minnesota, March 10, 2008 - Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers of the Deltec CozmoŽ Insulin Pump.
Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers (see below) of the Deltec CozmoŽ Insulin Pump.
Only 1023 recently manufactured pumps have been affected by this recall. These pumps were manufactured between November 2007 and January 2008. We have only been notified of 2 occurrences by customers, none of which have required any medical intervention
The reason for this recall is that the pumps may have an issue that affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user. Smiths Medical will be replacing all affected pumps.
After conducting a thorough investigation, Smiths Medical has concluded that the root cause of the motor issue was a manufacturing error with its component supplier. Through process control and process validation, this issue has now been corrected.
We will be notifying customers by mailing the recall letter via regular US Post and by telephoning customers. The Food and Drug Administration (FDA) has been informed of this action.
Any customer inquires related to this action should be addressed to Smiths Medical's customer service center at 1-800-826-9703.