Events

Recall of Broselow/Hinkle Pediatric Emergency System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Devices, a GE Healthcare Company.

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
    58857
  • Event Risk Class
    Class 2
  • Event Number
    Z-2704-2011
  • Event Initiated Date
    2011-04-26
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100428
  • 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
    Mask, oxygen - Product Code BYG
  • Reason
    Broselow pediatric emergency system kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.
  • Action
    GE issued an URGENT MEDICAL DEVICE CORRECTION letter dated April 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the affected product, isolate all affected product, complete the attached confirmation form and fax back per the instructions and return any unused product. For any product forwarded to any other healthcare institution, customers were instructed to forward a copy of the URGENT MEDICAL DEVICE CORRECTION letter to those institutions. For any questions contact Vital Signs Customer Service at 1-800-932-0760.

Device

Broselow/Hinkle Pediatric Emergency System
  • Model / Serial
    Expiration for kit is four years.   Oz Masks  #D075986 Class I Exempt Device  If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: AE-4700 AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW " Lot numbers of the affected modules are: 2009 K109 through K365 2010 P001 through P149510 (k) : K781055; Medical Device Listing   Blood Pressure Cuffs  If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: AE-4703, AE- 4700, AE-4706, AE-4707 " Lot numbers affected are: For the year 2009 LOT Number 2689 through LOT Number 3659 For the year 2010 LOT Number 0010 through LOT Number 2530 Any lot number that ends in the number 1 is NOT affected by the recall.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IL
  • Product Description
    Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA || The kit contains oxygen masks and blood pressure cuffs use on pediatric patients
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • Manufacturer Address
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA