FDA Medical Device Recalls (openFDA)
Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump
- Recall number
- Z-0210-05
- Recalling firm
- Smiths Medical MD, Inc.
- Product
- Deltec Cozmo Insulin Pump
- Status
- Terminated
- Initiated
- 2004-09-18
- Posted
- 2004-11-19
- Terminated
- 2005-08-19
- Reason
- The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A207742
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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