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U.S. Department of Health and Human Services

Class 3 Device Recall CADD Prizm

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  Class 3 Device Recall CADD Prizm see related information
Date Initiated by Firm January 19, 2007
Date Posted April 05, 2007
Recall Status1 Terminated 3 on May 25, 2007
Recall Number Z-0718-2007
Recall Event ID 37486
510(K)Number K960826  K973917  K000842  
Product Classification ambulatory infusion pump - Product Code FRN
Product Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.
Code Information Serial numbers affected:  691099, 691108, 691117, 691700, 691704, 691713, 691719, 691724, 691729, 691731, 691734, 691737, 691739, 691744, 691748, 691756, 691761, 691764, 691769, 691772, 691776, 691780, 691785, 691788, 691793, 691794, 691798.
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
Manufacturer Reason
for Recall		 The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.
FDA Determined
Cause 2		 Other
Action All consignees who have received the affected CADD-Prizm PCS II ambulatory infusion pumps and the CADD-Prizm VIP System ambulatory infusion pumps were contacted via telephone by February 1, 2007. The problem will be explained to the consignee and they will be asked to return the pumps to Smiths Medical MD in order for the problem to be corrected.
Quantity in Commerce 27
Distribution Nationwide.
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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