FDA Medical Device Recalls (openFDA)
Smiths Medical MD, Inc.: 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.
- Recall number
- Z-0566-05
- Recalling firm
- Smiths Medical MD, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2004-10-15
- Posted
- 2005-02-26
- Terminated
- 2006-06-25
- Reason
- 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.
- 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
- 2886 boxes (25 cartridges per box); EXPANDED RECALL additional 1440 boxes
- Distribution
- nationwide. Product only distributed within the US.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K020655
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 2183502
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28