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U.S. Department of Health and Human Services

Class 2 Device Recall Deltec Cozmo 3 mL Insulin Cartridge

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  Class 2 Device Recall Deltec Cozmo 3 mL Insulin Cartridge see related information
Date Initiated by Firm October 15, 2004
Date Posted February 26, 2005
Recall Status1 Terminated 3 on June 25, 2006
Recall Number Z-0566-05
Recall Event ID 30401
510(K)Number k020655  
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Additional labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged. do not use if package is opened or damaged, or if product appears damaged. Made in Mexico for: Deltec 1265 Grey Fox Road, St. Paul, MN 55112 USA, Smiths, smiths Medical - a part of Smiths Group plc.
Code Information Cartridge Lot Number 005X64 reorder # 21-1750-24 and Cartridge Lot Number 007X64 Reorder # 21-1750-24. EXPANDED RECALL 03/17/05 to include lot #009X64
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Customer Service Department
800-826-9703
Manufacturer Reason
for Recall		 Smiths Medical MD, Inc. (SMMD) has received several complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber. Firm expanded recall 03/17/05 to include one more lot, based on in-house testing and review of customer complaints.
FDA Determined
Cause 2		 Other
Action Consignees were mailed Customer Recall Notification Letter on 10/15/04. Customers are to inspect their inventory for the affected lot numbers and contact Smiths Medical Customer Services Department and return any unused Insulin Cartridges to Smiths Medical, who will replace the returned Insulin Cartridges. EXPANDED RECALL Customers were notified with an Urgent: Product Safety & Recall Notification beginning 03/17/05 with similar instructions as in the previous Notification. Customers are to inspect their inventory for the affected lot number, contact Smiths Medical Diabetes System Customer Service Department to make arrangements to have the unused Insulin Cartridges from the affected lot number returned to Smiths Medical, who will provide replacement cartridges.
Quantity in Commerce 2886 boxes (25 cartridges per box); EXPANDED RECALL additional 1440 boxes
Distribution nationwide. Product only distributed within the US.
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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