High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Recall Z-2128-2012 · Posted 2012-08-02
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2012-04-17
Date Terminated2012-08-23
Product Quantity4625
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.
Firm 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 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: [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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