Events

Recall of Device Recall Portex First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing,

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

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
    57906
  • Event Risk Class
    Class 2
  • Event Number
    Z-2651-2011
  • Event Initiated Date
    2011-02-11
  • Event Date Posted
    2011-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97727
  • 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
    Air/oxygen face mask, rebreathing - Product Code BYG
  • Reason
    A sticky substance on the inside and/ or outside of the mask.
  • Action
    Smiths Medical notified consignees by letter on 2/14/11 titled Urgent Medical Device Correction Notice via U.S. Mail (USA only) This Notice includes an Urgent Medical Device Correction Notice Confirmation Form that provides instructions to consignees to return unused affected product to Smiths Medical and to complete the effectivity tracking form. On 3/17/11 Smiths Medical issued an additional recall letter to extend the recall to 3 additional lots not included in the original recall letter dated 2/14/11. Also, the firm issued a recall letter on 3/17/11 to include the Value Pack (VP1302) General Anesthesia Kit to include 7 kit lots. Contact Recall Coordinator 1-800-348-6064 prompt 4, ext 2273

Device

Device Recall Portex First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing,
  • Model / Serial
    Lot Numbers:  09-50 10-08  10-17 10-21
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
  • Product Description
    First Breath ¿ PEDIATRIC Medium Concentration Oxygen Mask with Tubing, 213cm (7ft) (Non-latex) 50/CA || Reorder Number: 001471 || Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical
  • Manufacturer Address
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA