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Terminated

Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936

FDA Recall Z-0709-03 · Posted 2003-04-03

Recalling FirmI-Flow Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2003-03-05
Date Terminated2004-12-01
Product Quantity5,808 units

Reason for Recall

Wrong component may result in over infusion of medications.

Firm Action

Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.

Root Cause

Other

Distribution Pattern

States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923875SIDEKICK 50 PLUS AND SIDEKICK 100 PLUSI-Flow Corp. · 1993-05-13

Official Source

View FDA Recall →

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

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