Smiths Medical MD, Inc. Issued a Voluntary Recall of Specific Serial Numbers of the Deltec Cozmo® Insulin Pump
March 10, 2008 (Cozmo) - Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers (see below) of the Deltec Cozmo® 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 interventionThe 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.
Serial numbers for affected Deltec Cozmo® Insulin Pumps can be found here.
Comments
Hello: As a mom with a 13
Hello:
As a mom with a 13 year old type 1 - I am grateful to have D-Life website & TV documentary to view and help in my research. Today I am especially happy with you as my son's Cozmo Deltec pump is on this voluntary recall list. I called Smith medical right away (and as usual) they are taking care of the situation. If it were not for you website, I don't know when I would have been notified. On behalf of moms out there who try to stay on top of the type 1 topics - thank you so much for your excellent and helpful website.
Warm Regards,
Brenda Byers
& Alex Byers (Age 13)
My daughter's pump was on
My daughter's pump was on this recall as well. We have had 4 Cozmo pumps in the last 4 years. All of them have malfunctioned in one way or another. When we got the new one in November, which was on the recall, we had 6 hospital visits between November and February. All of them for DKA. The last one put her in ICU for 2 days. When we did a tally of the amount of insulin that had been administed since the last catridge change, she should have recieved 370 units of unsilin, and we still had 20 units left in the cartridge. I am wondering if the motor malfunction could also have cause too little insulin to be delivered. They have our pump in their hands. Why hasn't this issue been addressed as well? If there is a motor malfunction, why can't it go either way instead of just saying that it possibly could give too much? Are they afraid that if they find out kids have been hospitalized for this that people will stop using their pump? They are currently denying any fault in my daughter's situation, which is very frustrating. And they are refusing to give me any paperwork on the investigation on why my daughter's pump malfunctioned this time. We had no alerts like we had in the past that the pump was working incorrectly. We have since reverted back to shots, and my daughter's sugar stays between 100-140 which is a great place for her to be, especially since we were experiencing highs on a regular basis. her A1C went from 6-7 up to 13 over the course of 4 months. If anyone has information on this, I would be greatful for it.
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