Z-0566-05

Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No...

Name: Z-0566-05 Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No...
Creator: Smiths Medical MD, Inc.
Published: 2004-10-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-10-15 / Terminated

FDA source

Smiths Medical MD, Inc. began a recall of 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... on 2004-10-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0566-05
Status: Terminated
Initiated: 2004-10-15
Posted: 2005-02-26
Terminated: 2006-06-25
Recalling firm: Abbott Medical
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.
Product code: LZG Pump, Infusion, Insulin
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 root cause: 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.
Product codes and lots: 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

Product code LZG

K020655Class IIDeltec Insulin Infusion Pump and AccessoriesDeltec, Inc. / cleared 2002-08-13

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)