Product Wiki · Recalls · U.S. FDA — Device Enforcement

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit — recall Z-2131-2012

U.S. FDA — Device Enforcement · United States · 2012-04-17 · Class II

As described by U.S. FDA — Device Enforcement: Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2131-2012
Date of alert
2012-04-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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