Events

Recall of Device Recall HIgHFlo Subcutaneous Safety Needle Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Repro-Med Systems, 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
    76569
  • Event Risk Class
    Class 2
  • Event Number
    Z-0318-2018
  • Event Initiated Date
    2016-03-10
  • Event Date Posted
    2018-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153552
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    On 2/24/2016 during post sterilization inspection of part number f180 precision flow rate tubing, lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for part number #317036 5 x 6.5 st bag combo. the firm decided to recall precision flow rate tubing and rms high-flo subcutaneous safety needles sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. the firm determined that the issue was large than just the one lot and recalled the product via march 10, 2016 voluntary medical device corrections and removal notification to customers. the recall was conducted without fda notification.
  • Action
    On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.

Device

Device Recall HIgHFlo Subcutaneous Safety Needle Sets
  • Model / Serial
    Lot Numbers: 7.069/16, 7.068/16, 7.066/16, 7.065/16, 7.064/16, 7.063/16, 7.062/16, 7.061/16, 7.060/16, 7.059/16, 7.058/16, 7.057/16, 7.056/16, 7.055/16, 7.054/16, 7.053/16, 7.052/16, 7.051/16, 7.050/16, 7.049/16, 7.048/16 & 7.046/16.  Expiration: 2019-02
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in US
  • Product Description
    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS32609, RMS22609, RMS22606, RMS42609 & RMS32612.
  • Manufacturer
    Repro-Med Systems, Inc.

Manufacturer

Repro-Med Systems, Inc.
  • Manufacturer Address
    Repro-Med Systems, Inc., 24 Carpenter Rd, Chester NY 10918-1057
  • Manufacturer Parent Company (2017)
    Repro-Med Systems Inc
  • Source
    USFDA