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U.S. Department of Health and Human Services

Class 2 Device Recall Deltec Cozmo

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  Class 2 Device Recall Deltec Cozmo see related information
Date Initiated by Firm September 18, 2004
Date Posted November 19, 2004
Recall Status1 Terminated 3 on August 19, 2005
Recall Number Z-0210-05
Recall Event ID 30161
510(K)Number K020655  
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Deltec Cozmo Insulin Pump
Code Information Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A207742 
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
Manufacturer Reason
for Recall		 The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = DELTEC, INC.
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