Events

Rappel de Device Recall Water Soluble Lubricant

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 DeRoyal Processing Center.

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
    58148
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2013-2011
  • Date de mise en oeuvre de l'événement
    2011-02-07
  • Date de publication de l'événement
    2011-04-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98542
  • 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
    Patient Lubricant - Product Code KMJ
  • Cause
    Possible contamination due to sterilization issue. inspection of contract manufacturer found cgmp deficiencies.
  • Action
    The firm notified their consignees by a Re: DeRoyal Recall Of Triad Group Lubricating Jelly letter, dated Friday, March 18,2011. The letter discussed the reason for recall and the affected products. The letter asked customers to identify inventory using the attached spreadsheet and quarantine to prevent further use. Customers are to complete the spreadsheet regardless if they have effected product or not. The completed form can be faxed to 865-362-3716 or emailed to recalls@deroyal.com. All affected products should be return to DeRoyal at the address provided. Distributors are to forward a copy of the notice to their end-users. If there are questions or assistance is needed with the recall, Stephanie DeBusk should be contacted at 865-362-1037 or Sharon Cook at 865-362-6157.

Device

Device Recall Water Soluble Lubricant
  • Modèle / numéro de série
    31-702: 18040107, 18125741, 18150322, 18368014, 18605067, 18605067, 19032694, 19032694, 19136741, 19557491, 20023453,  20102637, 20190729, 20190729, 20023453, 20190729, 20510139, 20023453, 20190729, 21049840, 21049840, 21517201, 21780683, 21780683, 21517201, 21780683, 22025604, 22147169, 21517201, 21517201, 22269799, 22952133, 23474014, 23474014, 23474014, 24194532, 24194532, 24406620, 17950117, 19136741, 21517201, 21780683, 22147169, 22025604, 22595121, 23918771, 24406620, 20190729, 18040107, 18605067, 19032694, 19136741, 20190729, 18150322, 19032694, 20102637, 20190729, 20190729, 21517201, 22269799, 22269799, 24406620, 24406620, 17296856, 17950117, 18368014, 18368014, 18368014, 18605067, 19557491, 19557491, 20510139, 20634166, 21168988, 22952133, 22595121, 22898042, 22952133, 22269799, 24194532, 24194532, 24406620, 19557491, 19032694, 19032694, 20023453, 20023453, 20190729, 20510139, 20634166, 21517201, 21517201, 21517201, 22898042, 21517201, 23918771, 18040107, 18605067, 20023453, 20634166, 21049840, 21168988, 21517201, 22595121, 17950117, 17296856, 19136741, 19032694, 20190729, 20190729, 20190729, 20190729, 20190729, 20023453, 20634166, 21517201, 22025604, 21517201, 21517201, 23918771, 17950117, 18040107, 18368014, 18605067, 18605067, 19032694, 19218034, 19136741, 19557491, 20190729, 20190729, 20190729, 20510139, 21049840, 21049840, 21517201, 21780683, 22025604, 21517201, 21517201, 21517201, 21517201, 22952133, 22595121, 21517201, 23918771, 23474014, 24194532, 23474014, 24892314, 24194532, 22025604, 18040107, 18125741, 18368014, 18605067, 19032694, 19136741, 19218034, 20023453, 20102637, 20190729, 20190729, 20510139, 20634166, 21168988, 21517201, 21588464, 21517201, 20634166, 21517201, 21780683, 22025604, 22595121, 21517201, 22269799, 23474014, 24194532, 24194532, 20023453, 20190729, 20634166, 22595121, 22898042, 21517201, 23474014, 24641355 31-704: 17407430, 18395135, 18605075, 18605075, 19476391, 19476391, 19557520, 20510155, 20914037, 21049866, 21238801, 1397561, 21588481, 21746987, 22269810, 23474022, 23474022, 23750736, 23750736, 24406638, 24406638, 24406638, 17407430, 17407430, 17407430, 17950133, 18234024, 18395143, 18368031, 18368031, 18368031, 18605075, 18962021, 18962021, 18605075, 18962021, 18605075, 18962021, 18605075, 19089121, 19089121, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 19557520, 19792802, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20510155, 20656576, 20914037, 21049866, 20656576, 21049866, 21049866, 21238801, 21238801, 21397561, 21588481, 21588481, 21588481, 21746987, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22758218, 22269810, 23192682, 23192682, 23474022, 23474022, 23750736, 23474022, 23750736, 24175892, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 17950133, 18234024, 18368031, 18368031, 18368031, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 19476391, 19792802, 19557520, 19557520, 20510155, 20656576, 20656576, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21588481, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22758218, 22269810, 23474022, 23750736, 23750736, 23750736, 24175892, 23750736, 24175892, 24175892, 24175892, 24175892, 24406638, 24175892, 24175892, 24406638, 24406638, 24764187, 22269810, 18962021, 17407430, 18234024, 18234024, 18368031, 18395135, 18605075, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 17407430, 18234024, 19089121, 18605075, 19476391, 20510155, 20656576, 21397561, 21588481, 21588481, 21746987, 22531646, 22758218, 22269810, 22269810, 23192682, 23474022, 23192682, 23474022, 24406638, 24764187, 18605075, 19089121, 19476391, 19557520, 19792802, 20510155, 20914037, 21049866, 21049866, 21049866, 21238801, 23750736, 24406638, 24406638, 24406638, 23192682, 18962021, 21049866, 21588481, 23750736, 17407430, 17950133, 18234024, 18234024, 20510155, 21049866, 21238801, 21746987, 22037111, 20914037, 18605075, 23474022, 22758218, 17407430, 17407430, 17407430, 17950133, 17950133, 18234024, 18368031, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 18962021, 18605075, 18962021, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 20510155, 20510155, 19557520, 20510155, 20656576, 20656576, 20914037, 20914037, 20656576, 20656576, 21049866, 21049866, 21506318, 21746987, 21746987, 22037111, 22037111, 22269810, 22758218, 22758218, 22758218, 22269810, 22269810, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23474022, 23474022, 23474022, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 24406638, 21397561, 22269810, 23474022, 23750736, 24175892, 24764187, 19792802, 17407430, 17950133, 18234024, 18395143, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19792802, 19557520, 19557520, 19792802, 20510155, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20656576, 21238801, 21506318, 21397561, 21397561, 21588481, 21397561, 22037111, 22531646, 22531646, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23474022, 23750736, 23750736, 24175892, 24175892, 23750736, 24406638, 24406638, 24406638, 24406638, 24764187, 23192682, 17407430, 18605075, 18605075, 18605075, 19476391, 19476391, 20510155, 20914037, 21506318, 21588481, 22037111, 22758218, 22269810, 23474022, 23750736, 24175892, 24764187, 17950133, 18234024, 18368031, 18234024, 18605075, 19089121, 19089121, 18605075, 19476391, 1792802, 19557520, 20510155, 20510155, 20510155, 20914037, 21238801, 21238801, 21506318, 21397561, 21588481, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22758218, 22269810, 22758218, 22269810, 22531646, 23192682, 23192682, 23750736, 23750736, 24175892, 24175892, 24764187, 18605075, 17950133, 17950133, 18395143, 18368031, 18962021, 18605075, 19089121, 18605075, 19476391, 18605075, 19557520, 19557520, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21588481, 21746987, 22269810, 22531646, 22758218, 22269810, 23192682, 23474022, 23750736, 24406638, 24406638, 24406638, 24764187, 19476391, 21049866, 22037111, 17950133, 18395143, 18368031, 18605075, 17950133, 18368031, 18605075, 19089121, 19476391, 19557520, 20510155, 20656576, 21238801, 21397561, 21588481, 21746987, 22037111, 22758218, 22758218, 23192682, 23750736, 24175892, 24406638, 18605075, 20510155, 20510155, 20656576, 21049866, 21049866, 21746987, 21746987, 22269810, 23192682, 23192682, 24406638, 17950133, 18368031, 18605075, 19792802, 20510155, 20914037, 21049866, 21397561, 21588481, 21588481, 21588481, 22269810, 23192682, 23192682, 23192682, 23474022, 23750736, 24175892, 24175892, 24406638, 24764187, 24764187, 18234024, 18234024, 18234024, 18234024, 18962021, 19089121, 19476391, 19476391, 19557520, 19557520, 20510155, 20510155, 20510155, 22758218, 23750736, 19476391, 19089121, 19476391, 19089121, 19476391, 20510155, 20510155, 20656576, 21238801, 18605075, 22531646, 22758218, 20656576, 22037111, 17407430, 17950133, 18395143, 18234024, 18368031, 18368031, 18605075, 18605075, 18605075, 18605075, 18605075, 18962021, 19089121, 18962021, 18605075, 18605075, 19476391, 19476391, 19089121, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20510155, 20914037, 20914037, 18234024, 20656576, 20914037, 21049866, 21049866, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21397561, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23750736, 23750736, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24406638, 24764187, 17407430, 23192682, 23474022, 24175892, 24175892, 21397561, 21588481, 21746987, 22037111, 22037111, 22269810, 22269810, 22269810, 22531646, 22269810, 23474022, 24406638, 24764187, 24406638, 24764187, 17407430, 18234024, 18368031, 18395135, 18395135, 18605075, 18605075, 18962021, 18962021, 18962021, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21506318, 17950133, 17950133, 17950133, 18234024, 18368031, 18605075, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20656576, 20914037, 20914037, 24406638, 24764187, 18962021, 19476391, 19792802, 19792802, 20510155, 20656576, 21588481, 21746987, 22037111, 22531646, 23192682, 23474022, 23750736, 18234024, 19476391, 21238801, 22037111, 23192682, 24175892, 21397561, 21746987, 22531646, 22269810, 23474022, 24175892, 21049866 31-938: 18368057, 17070224, 17407448, 17407448, 18368057, 20656584, 21588499, 22147193, 20510180, 21747007, 24194559, 18500214, 20656584, 22269836, 23750744, 21747007, 24046927, 24194559, 24406646, 20069646, 21672797, 21672797, 18368057, 24406646, 17407448, 17407448, 18368057, 18500214, 18500214, 18500214, 19089148, 19089148, 19089148, 19089148, 19089148, 18500214, 20069646, 19940879, 20069646, 20510180, 20656584, 20656584, 20656584, 20069646, 20510180, 21672797, 21747007, 21747007, 21907509, 22147193, 22269836, 21907509, 22269836, 22853565, 21747007, 21907509, 23382419, 23750744, 24046927, 24194559, 24406646, 24194559, 17407448, 18500214, 18500214, 19089148, 20069646, 19940879, 20656584, 21672797, 22269836, 23750744, 19089148, 20656584, and 22269836.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Lubricating Jelly packaged as follows: || (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; || (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor: DeRoyal, 200 DeBusk Lane, Powell, TN 37849, USA; || (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA || Lubricating body orifices.
  • Manufacturer
    DeRoyal Processing Center

Manufacturer

DeRoyal Processing Center
  • Adresse du fabricant
    DeRoyal Processing Center, 1703 Highway 33 S, New Tazewell TN 37825-5043
  • Société-mère du fabricant (2017)
    Deroyal Industries Inc.
  • Source
    USFDA