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Terminated

Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

FDA Recall Z-0432-05 · Posted 2005-01-26

Recalling FirmHarvard Clinical Technology
Recall StatusTerminated
Product CodeMEA
Date Initiated2004-11-03
Date Terminated2012-05-07
Product Quantity154 units

Reason for Recall

Potential pump motor/encoder assembly failure may cause over infusing medication in patients

Firm Action

Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.

Root Cause

Other

Distribution Pattern

AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033054HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMPHarvard Clinical Technology · 2003-12-16

Official Source

View FDA Recall →

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

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