Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
This recall has been terminated (originally issued July 3, 2003).
- Company
- Deltec, Inc
- Recall Initiated
- June 23, 2003
- Posted
- July 3, 2003
- Terminated
- July 2, 2004
- Recall Number
- Z-0980-03
- Quantity
- 135 pumps
- Firm Location
- St Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
Lot / Code Info
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
Root Cause
Other
Action Taken
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.