Events

Recall of AirLife

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 2200 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
    64971
  • Event Risk Class
    Class 2
  • Event Number
    Z-1947-2013
  • Event Initiated Date
    2013-04-22
  • Event Date Posted
    2013-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117567
  • 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
    Carefusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.
  • Action
    CareFusion sent an URGENT RECALL NOTICE letter dated April 22, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to complete and return an attached Distributor Acknowledgement Form within fifteen (15) days of receipt indicating their acknowledgement of the URGENT RECALL NOTICE and indicate if they have any affected product on hand. They are further requested to perform a 100% physical inventory to verify if any of the affected product codes/lot numbers are in stock within their distribution network/facility. In addition, customers are requested to forward the Customer Acknowledgement Form, the Customer Notification Letter, the Certificate of Destruction Form, the Pictures of Location of Lot Numbers on Case/Product, and the Frequently Asked Questions (FAQs) to all end users which they have distributed the affected product. For questions call 847-473-7097.

Device

AirLife
  • Model / Serial
    1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668;  2) Product Code 2K8004; Lot Number: 0000355673;  3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677;  4) Product Code 2K8034; Lot Number: 0000355688;  5) Product Code 2K8035; Lot Number: 0000358023;  6) Product Code 2K8037; Lot Number: 0000358025;  7) Product Code 2K8040; Lot Number: 0000358026
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
  • Product Description
    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; || 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; || 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; || 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; || 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; || 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; || 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock || Product Usage: Pulmonary resuscitation
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Manufacturer Address
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA