BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2130-2012 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2130-2012
    Event ID
    62538
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2012
    Initiation Date
    April 17, 2012
    Classification Date
    August 2, 2012
    Termination Date
    August 23, 2012
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

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

    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 Info

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

    Distribution

    Nationwide distribution

    Quantity

    N/A