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Terminated

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

FDA Recall Z-0134-2008 · Posted 2008-02-26

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2007-08-14
Date Terminated2008-10-31
Product Quantity3 CD-ROMs

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

UT, MD, CO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062892EUKAREEumed Biotechnology Co., Ltd. · 2007-01-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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