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Terminated

CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.

FDA Recall Z-1235-2010 · Posted 2010-04-05

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2009-12-23
Date Terminated2011-12-10
Product Quantity1

Reason for Recall

The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.

Firm Action

Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump.

Root Cause

Employee error

Distribution Pattern

MI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400Sims Deltec, Inc. · 1998-11-04

Official Source

View FDA Recall →

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

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