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U.S. Department of Health and Human Services

Class 2 Device Recall Sentry Pro Medication Safety Software

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 Class 2 Recall
Sentry Pro Medication Safety Software
see related information
Date Posted February 26, 2008
Recall Status1 Terminated on October 31, 2008
Recall Number Z-0134-2008
Recall Event ID 44799
Premarket Notification
510(K) Number
K062892 
Product Classification Pump, Infusion - 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, Minnesota 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = EUMED BIOTECHNOLOGY CO., LTD.
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