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Terminated

Sodium Chloride Injection USP, manufactured by IV Flush LLC

FDA Recall Z-0546-05 · Posted 2005-03-01

Recalling FirmIV Flush LLC
Recall StatusTerminated
Product CodeFOZ
Date Initiated2005-01-26
Date Terminated2008-09-17

Reason for Recall

Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.

Firm Action

The firm initiated the recall by fax to distributors on 01/26/2005. On 2/16/2005 the firm faxed a second recall letter with return reciept response card to all consignees.

Root Cause

Other

Distribution Pattern

Product was distributed nationwide.

Official Source

View FDA Recall →

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

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