Events

Recall of Device Recall Smiths Pneupac babyPAC 100

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

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
    34275
  • Event Risk Class
    Class 2
  • Event Number
    Z-0436-06
  • Event Initiated Date
    2005-12-05
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43414
  • 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
    Ventilator, Emergency, Powered (Resuscitator) - Product Code BTL
  • Reason
    A potential safety related problem associated with the pnuepac babypac ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
  • Action
    Consignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair.

Device

Device Recall Smiths Pneupac babyPAC 100
  • Model / Serial
    0504244, 0505158, 0506211, 0506218, 0506242, 0506248, 0506254, 0506265, 0506283, 0506289, 0506321, 0506346, 0506358, 0507127, 0507139, 0507234, 0507235, 0507236, 0507248, 0507249, 0507265, 0508173, 0508174, 0508195, 0508196, 0508197, 504227, 504254, 505139, 505142, 505145, 505257, 505271, 505276, 505286, 506155, 506158, 506169, 506171, 506194, 506233, 506241, 506343, 507317
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, IN,MN, NY, PA, TN, TX
  • Product Description
    Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Manufacturer Address
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA