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Terminated

Medex 3000 Series Syringe Infusion Pumps

FDA Recall Z-0813-04 · Posted 2004-07-20

Recalling FirmMedex Inc
Recall StatusTerminated
Product CodeCAJ
Date Initiated2004-02-16
Date Terminated2005-11-07
Product Quantity7896 units

Reason for Recall

Inadequate warning label: Medex has determined that it is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.

Firm Action

Consignees were notified by letter starting 2/2004 and continues to the present

Root Cause

Other

Distribution Pattern

Nationwide, China, Hong Kong & UK

Official Source

View FDA Recall →

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

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