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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Recall Number Z-2128-2012
Classification Class II
Code Info Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568
Product Distributed Qty 4625
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.

Event Detail

Event Id 62538
Product Type Devices
Status Completed
Recalling Firm ICU Medical, Inc.
City San Clemente
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution