ICU Medical, Inc. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

Recommended Action

Per FDA guidance

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.