Recall Z-2206-2008 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General Hosp. , Item Number: 460760451 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
| Date | Sep 16, 2008 (initiated Jun 11, 2008) |
| Status | Terminated |
| Reason | Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility. |
| Root cause | Process change control |
| 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. |
| Quantity | 120 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal, Apr 13, 2006 |