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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 Device Recall Sentry Pro Medication Safety Softwaresee related information
Date Initiated by FirmAugust 14, 2007
Date PostedFebruary 26, 2008
Recall Status1 Terminated 3 on October 31, 2008
Recall NumberZ-0134-2008
Recall Event ID 44799
510(K)NumberK062892 
Product Classification infusion pump programming software - Product Code FRN
ProductSmiths 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.
FEI Number 2183502
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 2		Software design
ActionA 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 Commerce3 CD-ROMs
DistributionUT, MD, CO
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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