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Recall Observatory FDA recall evidence

Device product

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

Z-2131-2012

April 17, 2012

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 62538
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2131-2012

Official wording

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.

Code information: Part Number AG8137 510(k) K052865 Lot number 2466161

Distribution pattern: Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.