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Terminated

Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.

FDA Recall Z-1445-06 · Posted 2006-08-26

Recalling FirmDelphi Medical Systems
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-03-29
Date Terminated2006-10-16
Product Quantity22 US and 147 international.

Reason for Recall

Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.

Firm Action

Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.

Root Cause

Other

Distribution Pattern

Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSImed Corp. · 1996-03-20

Official Source

View FDA Recall →

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

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