Events

Recall of Device Recall Puritan absorbent foam tipped applicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Puritan Medical Products Co., LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70270
  • Event Risk Class
    Class 2
  • Event Number
    Z-1278-2015
  • Event Initiated Date
    2014-12-22
  • Event Date Posted
    2015-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132741
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Applicator, absorbent tipped, sterile - Product Code KXG
  • Reason
    Shaft breaks so that adequate patient specimen sample cannot be obtained.
  • Action
    Consignees were initially notified of the recall via phone on 12/23/2014 and 12/29/2014. They were informed that the product may have been over exposed to gamma radiation, resulting in brittle sticks. They were instructed to not use the product for patient sampling and to return any product remaining in inventory to Puritan.

Device

Device Recall Puritan absorbent foam tipped applicator
  • Model / Serial
    Lot Number 3111, Expiration date: 2016/04
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MS, ME, GA, and NC.
  • Product 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.
  • Manufacturer
    Puritan Medical Products Co., LLC

Manufacturer

Puritan Medical Products Co., LLC
  • Manufacturer Address
    Puritan Medical Products Co., LLC, 31 School Street, P.O. Box 149, Guilford ME 04443-0149
  • Manufacturer Parent Company (2017)
    Puritan Medical Products Company Llc
  • Source
    USFDA