Events

Recall of Device Recall Portex 1st Response Adult Manual Resuscitators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sims Portex 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
    25083
  • Event Risk Class
    Class 1
  • Event Number
    Z-0809-03
  • Event Initiated Date
    2002-11-15
  • Event Date Posted
    2003-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25126
  • 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, Manual (Resuscitator) - Product Code BTM
  • Reason
    Peep valve set at the highest level and could result in patient injury.
  • Action
    Portex notiifed direct customers by telephone (medical facilities and distributors) on 11/15/2002 and 11/18/2002 inforrming them to isolate and hold inventory. A letter dated 11/19/02 issued by Fed''X to return product or remove/discard PEEP valve from unit and complete the response form.

Device

Device Recall Portex 1st Response Adult Manual Resuscitators
  • Model / Serial
    REF 8500P: Resuscitator, Bag Reservoir, Peep Valve Lot #''s 020607,020620, 020622, 020703, 020710, 020829, 200214, 200215, 200216
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. AL, CA, CO, IA, IL, FL, GA, LA, KS, KY, MA, ME, MN, MO, MS, NC,NM, NY, OK, SC, TN, TX, WA WY, UT, VA
  • Product Description
    Portex 1st Response Adult Manual Resuscitators || Ref: 8500P
  • Manufacturer
    Sims Portex Inc.

Manufacturer

Sims Portex Inc.
  • Manufacturer Address
    Sims Portex Inc., 10 Bowman Drive, Keene NH 03431
  • Source
    USFDA