BEUDAMED
    FDA Enforcement Class II Terminated

    Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.

    Recall: Z-1278-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1278-2015
    Event ID
    70270
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Puritan Medical Products Co., LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 25, 2015
    Initiation Date
    December 22, 2014
    Classification Date
    March 13, 2015
    Termination Date
    March 18, 2015
    Address
    31 School Street, P.O. Box 149, Guilford, ME, 04443-0149, United States

    Description

    Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.

    Reason

    Shaft breaks so that adequate patient specimen sample cannot be obtained.

    Code Info

    Lot Number 3111, Expiration date: 2016/04

    Distribution

    Distributed in the states of MS, ME, GA, and NC.

    Quantity

    9 cases of 500 applicators each