Events

Rappel de Device Recall HIgHFlo Subcutaneous Safety Needle Sets

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Repro-Med Systems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76569
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0318-2018
  • Date de mise en oeuvre de l'événement
    2016-03-10
  • Date de publication de l'événement
    2018-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153552
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Set, administration, intravascular - Product Code FPA
  • Cause
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in US
  • Description du dispositif
    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.
  • Adresse du fabricant
    Repro-Med Systems, Inc., 24 Carpenter Rd, Chester NY 10918-1057
  • Société-mère du fabricant (2017)
    Repro-Med Systems Inc
  • Source
    USFDA