BEUDAMED
    FDA Recall Terminated

    ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.

    Recall: Z-1300-04 · Initiated June 7, 2004

    Recall

    Recall Number
    Z-1300-04
    Event Number
    29463
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2004
    Posted
    July 31, 2004
    Terminated
    September 21, 2004
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.

    Reason

    The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).

    Action

    The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization.

    Distribution

    The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX

    Quantity

    270 units