Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for fluid flow directional control an
FDA device recall Z-2205-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- 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.
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 490,250
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-06-11
- Date posted
- 2008-09-16
- Date terminated
- 2010-04-13
- Location
- San Clemente, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK (K060231) | Elcam Medical Acal | 2006-04-13 |