Deltec, Inc Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
Brand
Deltec, Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Deltec, Inc is recalling Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software due to Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, NC, WA
Page updated: Jan 10, 2026