Class 2 Device Recall Sentry Pro Medication Safety Software

• Date Initiated by Firm: August 14, 2007
• Date Posted: February 26, 2008
• Recall Status: Terminated on October 31, 2008
• Recall Number: Z-0134-2008
• Recall Event ID: 44799
• 510(K)Number: K062892
• Product Classification: infusion pump programming software - Product Code FRN
• Product: Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator; REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA
• Code Information: Catalog Number: 21-6275-51, Software Version B.
• Recalling Firm/ Manufacturer: Smiths Medical MD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• Manufacturer Reason for Recall: Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.
• FDA Determined Cause: Software design
• Action: A Smiths Medical MD employee visited the consignees between August 14 and 31, 2007, to verbally notify them of the recall, collect the recall CD-ROM containing the affected software and replace with the updated software.
• Quantity in Commerce: 3 CD-ROMs
• Distribution: UT, MD, CO
• 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 = EUMED BIOTECHNOLOGY CO., LTD.