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Terminated

ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.

FDA Recall Z-0870-06 · Posted 2006-05-17

Recalling FirmExcelsior Medical Corp
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-03-21
Date Terminated2006-12-07
Product Quantity3911 units

Reason for Recall

Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.

Firm Action

An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list.

Root Cause

Other

Distribution Pattern

Nationwide and Quebec, Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914988500 INFUSERExcel Medical, Inc. · 1992-04-06

Official Source

View FDA Recall →

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

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