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Terminated

Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)

FDA Recall Z-0741-03 · Posted 2003-04-18

Recalling FirmI-Flow Corporation
Recall StatusTerminated
Date Initiated2003-03-18
Date Terminated2003-11-20
Product Quantity2638 units

Reason for Recall

Overinfusion due to misassembly.

Firm Action

Recall letter was sent to sole distributor, B Braun FRance by email on 3/18/2003. Return of stock and subrecall was requested. Consignee has acknowledged implementing subrecall.

Root Cause

Other

Distribution Pattern

Only in France to distributor B. Braun Medical, France

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991513HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVOI-Flow Corp. · 1999-06-21

Official Source

View FDA Recall →

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

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