BEUDAMED
    FDA Recall Terminated

    Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument

    Recall: Z-0215-05 · Initiated April 29, 2004

    Recall

    Recall Number
    Z-0215-05
    Event Number
    30366
    Firm
    Premier Dental Products Co
    FEI Number
    2511556
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2004
    Posted
    November 20, 2004
    Terminated
    June 7, 2006
    Address
    1710 Romano Dr, Plymouth Meeting, PA, 19462-2822

    Description

    Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument

    Reason

    Cryogen can escape from canister through the seal ring

    Action

    The recalling firm issued letters to their customers informing them of an enhancement available for the product. The letters are not dated but were issued between 5/02 and 3/04

    Distribution

    The product was shipped to distributors and physicians nationwide. The product was shipped to government accounts in CA, DC, FL, LA, MD, MT, NY, SD, TX. The product was also sold in Iceland, Taiwan, Korea, Mexico, Spain, Columbia, Thailand, Singapore, South Africa, Canada, Costa Rica, Panama, Venezuela, and United Kingdom.

    Quantity

    1060 units