Events

Recall of Vital Signs

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
    60016
  • Event Risk Class
    Class 2
  • Event Number
    Z-0939-2012
  • Event Initiated Date
    2011-10-17
  • Event Date Posted
    2012-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106353
  • 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
    Oxygen Administration Kit - Product Code OGL
  • Reason
    Povidone iodine pads included in the vital signs broselow pediatric emergency kit may be contaminated with elizabethkinga meningoseptica.
  • Action
    GE Healthcare sent a recall letter/return response form dated October 17, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to not use the affected product, isolate and discard all affected product. Fill out the attached Confirmation form and fax back to 800-535-7923 per the instructions to obtain replacement Busse IV Start Kits. Also, consignees were instructed to return the attached response form even if no recalled product was in their inventory. If they forwarded any affected product to any other healthcare institutions, they should forward a copy of the letter to those institutions. For any questions regarding this recall call 1-800-932-0760.

Device

Vital Signs
  • Model / Serial
    Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor.  Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN  Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV  Lot codes of the Broselow Kits and Intra Venous Modules that contain affected Povidone Iodine Pads: 2008: 228F-366F 2009: 010K-258K and 010L-258L
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Foreign
  • Product Description
    Broselow/Hinkle Pediatric Emergency System || Vital Signs Inc. || 20 Campus Road || Totowa, NJ 07512 USA || The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
  • 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