Recall Z-2129-2012 ยท DQO Catheter, Intravascular, Diagnostic
ICU Medical, Inc.
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
| Date | Aug 2, 2012 (initiated Apr 17, 2012) |
| Status | Terminated |
| Reason | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. |
| Root cause | Nonconforming Material/Component |
| Action | ICU Medical sent an Urgent Medical Device Recall letter dated April 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to inspect inventory, destroy affected products according to hospital protocol, complete and return verification form and contact ICU Customer Service to order replacement products. The letter states that ICU Medical will credit customer for any product destroyed once the completed verification form is received. This recall should be carried out to the user level and passed on to all those w |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052865 | HOSPIRA CATH LAB CONVENIENCE KITS Icu Medical, Inc., Dec 22, 2005 |