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Recall Observatory FDA recall evidence

Device product

94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

Z-2130-2012

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-2130-2012

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 B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687.

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.