Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
FDA Recall Z-1206-2012 · Posted 2012-03-14
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2012-01-02
Date Terminated2013-07-25
Product Quantity595 (WI )+ 864 (DC) = 1459
Reason for Recall
Pumps rendered inoperable at power up (displaying a blank screen and alarm).
Firm Action
Smiths Medical ASD, Inc. contacted two consignees by telephone in November 2010 and January 2011. Smiths Medical worked with one of the two customers to correct 540 of the 595 devices (91%) while on-site in January 2011. The remaining devices were corrected by hospital personnel.
The other customer was also made aware of the issue, root cause and corrective action. This customer reported to Smiths Medical that they understood the issue, but did not want Smiths Medical to perform the correction on their pumps at the time (January 2011). They preferred to send their pumps to Smiths Medical for repair, as and when needed. As of December 2011, The hospital has returned 67 devices to Smiths Medical.
For questions regarding this recall call 651-628-7477.
Root Cause
Vendor change control
Distribution Pattern
Nationwide Distribution including WI and DC
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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