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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Icu Medical, Inc.
- Recall Initiated
- June 11, 2008
- Posted
- September 16, 2008
- Terminated
- April 13, 2010
- Recall Number
- Z-2206-2008
- Quantity
- 120
- Firm Location
- Amanecer San Clemente, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
Lot Number: 41-501-LA
Root Cause
Process change control
Action Taken
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.