Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA device recall Z-2131-2012 · posted 2012-08-02 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQO
- Distribution
- Nationwide distribution
- Date initiated
- 2012-04-17
- Date posted
- 2012-08-02
- Date terminated
- 2012-08-23
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA CATH LAB CONVENIENCE KITS (K052865) | Icu Medical, Inc. | 2005-12-22 |