Class 2 Device Recall Deltec CADDPrizm

• Date Initiated by Firm: June 23, 2003
• Date Posted: July 03, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-0980-03
• Recall Event ID: 26550
• 510(K)Number: K000842
• Product Classification: Pump, Infusion - Product Code FRN
• Product: Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
• Code Information: 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
• Recalling Firm/ Manufacturer: Deltec, Inc; 1265 Grey Fox Road; St Paul MN 55112
• For Additional Information Contact: Mike Herbert ; 651-628-7049
• Manufacturer 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.
• FDA Determined 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 in Commerce: 135 pumps
• Distribution: The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN