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Terminated

Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096

FDA Recall Z-0768-2007 · Posted 2007-04-26

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2007-02-03
Date Terminated2011-02-10
Product Quantity23,519

Reason for Recall

Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

Firm Action

Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982640MEDEX 3000 SERIES SYRINGE INFUSION PUMPMedex, Inc. · 1999-04-06

Official Source

View FDA Recall →

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

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