Events

Recall of Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD 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
    77402
  • Event Risk Class
    Class 2
  • Event Number
    Z-2670-2017
  • Event Initiated Date
    2017-04-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155955
  • 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, hypodermic, single lumen - Product Code FMI
  • Reason
    Smiths medical became aware on january 11, 2017, that syringe assemblies provided by nipro medical corporation contained pin holes in the side wall of the hub. the defect was not detected during smiths medical incoming inspection. the syringe assemblies were used to manufacture seven (7) finished good lots of hypodermic needle pro¿ needles, smiths medical part numbers el 1915 and sb5021.
  • Action
    Smiths Medical sent an "Urgent Medical Device Recall Notice" dated April 04, 2017. The letter was addressed to Quality Assurance Manager & Associate Sourcing Consultant. The letter listed the Affected devices described the Reason for Recall, & Risk to Health. Requested consignee to complete Urgent Medical Device Recall Response Form within 10 days of receipt and send it to: fieldactions@smithsmedical.com. For further questions, please call (603) 352-3812

Device

Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA
  • Model / Serial
    3297460,3297461 Model No. EL1915.  3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : IN
  • Product Description
    Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA