FDA Medical Device Recalls (openFDA)
Deltec, Inc: Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
- Recall number
- Z-0980-03
- Recalling firm
- Deltec, Inc
- Product
- Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
- Status
- Terminated
- Initiated
- 2003-06-23
- Posted
- 2003-07-03
- Terminated
- 2004-07-02
- Reason
- Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
- Root cause
- Other
- Action
- A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.
- Quantity
- 135 pumps
- Distribution
- The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
- Lot, serial or model codes
- Pump Serial numbers 658825, 658837, 658840, 658842, 658844 - 658865, 658867, 658869 - 658896, 658898 - 658918, 658920 - 658936, 658941, 658943 - 658947, 658949, 662473 - 662477, 662483, 662485, 662488 - 662490, and 662635 - 662659
- 510(k) numbers
- ["K000842"]
- PMA numbers
- not on file
- Product code
- FRN
- 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