BEUDAMED
    FDA Recall Terminated

    Penner Manufacturing Transfer Electric Superior right entry, Patient Transfer/Lift System, Models 384000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.

    Recall: Z-1916-2011 · Initiated January 19, 2009

    Recall

    Recall Number
    Z-1916-2011
    Event Number
    56977
    Firm
    Penner Mfg Inc
    FEI Number
    1922538
    Product Code
    FNG
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 19, 2009
    Posted
    April 8, 2011
    Terminated
    April 8, 2011
    Address
    102 Grant St, Ste A, Aurora, NE, 68818-3200

    Description

    Penner Manufacturing Transfer Electric Superior right entry, Patient Transfer/Lift System, Models 384000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.

    Reason

    Incomplete weld on the pillar mounting bracket

    Action

    The firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax to 402 694-5844 or mail to Penner Manufacturing Inc, 102 Grant Street, Aurora, NE 68818, Attn: Quality Assurance Manager. Penner stated in the letter, if welds are not complete (no weld), discontinue use and contact the Quality Assurance Manager at Penner Manufacturing immediately at 402-694-5003. If you have any questions, contact the Quality Assurance Manager at 402-694-5003.

    Distribution

    Worldwide distribution: USA and countries including: Canada and Mexico.

    Quantity

    8 lifts