Events

Recall of Device Recall 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 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
    52694
  • Event Risk Class
    Class 2
  • Event Number
    Z-1912-2009
  • Event Initiated Date
    2009-06-30
  • Event Date Posted
    2009-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83669
  • 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
    Needle, aspiration and injection, disposable - Product Code GAA
  • Reason
    Not compatible: the luer connector on the intraosseus needle provided does not fit securely on the luer connection of the iv extension set in the module.
  • Action
    Vital Signs, Inc. issued an "Urgent Medical Device Correction" letter dated June 30, 2009 to all direct and indirect accounts by first class mail. Consignees were informed of the affected device, asked to complete a Confirmation form for return and to return unused product for replacement. For further questions, contact Vital Signs, Inc. at 1-973-790-1330 extension 404.

Device

Device Recall Broselow/Hinkle Pediatric Emergency System
  • Model / Serial
    Model Numbers: 7700BIO, 7700GIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2, 7730BLU5, 7730GRN5, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5, 7730FLY, 7730MOD, 7730ALS and 7730IALS; and Lot Numbers: (2008) 245F through 366F and (2009) 001K through 149K.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
  • Product Description
    Broselow/Hinkle Pediatric Emergency System; || Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, || INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ. || The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes.
  • Manufacturer
    Vital Signs Inc

Manufacturer

Vital Signs Inc
  • Manufacturer Address
    Vital Signs Inc, 20 Campus Rd, Totowa NJ 07512
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    USFDA