Z-0134-2008

Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software...

Name: Z-0134-2008 Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software...
Creator: Smiths Medical MD, Inc.
Published: 2007-08-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-08-14 / Terminated / root cause: software

FDA source

Smiths Medical MD, Inc. began a recall of Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator REF 21-6275-51 RX only, Smiths... on 2007-08-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0134-2008
Status: Terminated
Initiated: 2007-08-14
Posted: 2008-02-26
Terminated: 2008-10-31
Recalling firm: Abbott Medical
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
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA root 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
Product codes and lots: Catalog Number: 21-6275-51, Software Version B.

Product code FRN

K062892Class IIEukareEumed Biotechnology Co., Ltd. / cleared 2007-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)