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Terminated

Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065

FDA Recall Z-0687-03 · Posted 2003-03-27

Recalling FirmI-Flow Corporation
Recall StatusTerminated
Product CodeMEB
Date Initiated2003-03-04
Date Terminated2004-04-14
Product Quantity2,832 units

Reason for Recall

Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.

Firm Action

Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.

Root Cause

Other

Distribution Pattern

CA, OH, WA, TX, UT, SC, MI, IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932740HOMEPUMP NSFBlock Medical, Inc. · 1993-10-06

Official Source

View FDA Recall →

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

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