FDA Medical Device Recalls (openFDA)
Deltec, Inc: Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.
- Recall number
- Z-0798-03
- Recalling firm
- Deltec, Inc
- Product
- Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.
- Status
- Terminated
- Initiated
- 2003-03-14
- Posted
- 2003-05-09
- Terminated
- 2004-07-02
- Reason
- A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner.
- Root cause
- Other
- Action
- Recall Notification letters were sent to the consignees on March 14, 2003. The letters gave recommendations for avoiding the problem, stated that updated software to prevent the problem would be introduced, and requested that the customer call a toll-free phone number to arrange replacement of their affected pump.
- Quantity
- 913 pumps
- Distribution
- The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.
- Lot, serial or model codes
- All units distributed since product introduction in December 2002 are involved.
- 510(k) numbers
- ["K020655"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 2183502
- Firm city
- St 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