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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012
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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568 Class II 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. 4625 Z-2128-2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment. Part Number 460730418 510(k) K052865 Lot number 2444750 Class II 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. Z-2129-2012
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing Part Number B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687. Class II 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. Z-2130-2012
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit Part Number AG8137 510(k) K052865 Lot number 2466161 Class II 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. Z-2131-2012
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