Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
FDA Recall Z-2205-2008 · Posted 2008-09-16
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2008-06-11
Date Terminated2010-04-13
Product Quantity490,250
Reason for Recall
Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
Firm Action
Every customer both direct and distributors who have purchased the affected lots were mailed a Product Recall Letter with attached fax-back Product Inventory Summary attachment on 06/11/2008 via fax and followed by UPS overnight delivery. The Product Recall Letter informed the customers of the reason for the recall and instructed them to complete and return the attached Product Inventory Summary. Instructions were also given for returning product in their inventory to ICU.
Root Cause
Process change control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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