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U.S. Department of Health and Human Services

Class 2 Device Recall Deltec CADDPrizm

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  Class 2 Device Recall Deltec CADDPrizm see related information
Date Initiated by Firm June 23, 2003
Date Posted July 03, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIMS DELTEC, INC.
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