—#110876

Product

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052865
Affected lot / code info: Part Number 460730418 510(k) K052865 Lot number 2444750

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 who need to be aware within your organization or any other organization the device may have been transferred to. Should you have any questions or require assistance relating to this recall please contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: Nationwide distribution

Timeline

Recall initiated: 2012-04-17
Posted by FDA: 2012-08-02
Terminated: 2012-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.