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Terminated

Infusion Dynamics Power Infuser pump. Model number M100B-3A

FDA Recall Z-0062-05 · Posted 2004-11-02

Recalling FirmInfusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics
Recall StatusTerminated
Product CodeFRN
Date Initiated2004-09-21
Date Terminated2005-02-07
Product Quantity255 units

Reason for Recall

Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.

Firm Action

The recalling firm issued a recall letter dated 9/20/04 to their customers informing them of the problem and the need to return the units.

Root Cause

Other

Distribution Pattern

The products were shipped to dealers in TX, MO, and VT; medical facilities in CA, NV, and NY. The product was also shipped to government accounts in PA and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030739INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGEInfusion Dynamics, Inc. · 2004-01-14K992044INFUSION DYNAMICS POWER INFUSER MODEL M100BInfusion Dynamics, Inc. · 1999-09-08

Official Source

View FDA Recall →

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

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