Events

Rappel de WELCON Catheterization Tray

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 Nurse Assist, 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
    60412
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0502-2012
  • Date de mise en oeuvre de l'événement
    2011-09-02
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106012
  • 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
    Catheter, urological - Product Code KOD
  • Cause
    Nurse assist, inc. received a recall notice from the triad group. this recall has been initiated due to a recall of the pvp solution packs manufactured by the triad group that are contained in certain procedure trays.
  • Action
    Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.

Device

WELCON Catheterization Tray
  • Modèle / numéro de série
    Assembly ID UT70101002U and UT70101400U. Lot Numbers: 905184 (1999116), 905240 (2013784), 905306 (2022227), 906320 (2050130), 906326 (2050141), 907177 (2075692), 907229 (2079816), 909270 (2152734), 910007 (2165988), 910224 (2183856), 911074 (2205933), 912006 (2242897), 912245 (2265322), 1001328 (2299790), 1002197 (2324937), 1002350 (2342704), 1003055 (2346521), 1003163 (2362102), 1003337 (2376018), 1004331 (2412783), 1005322 (2447048), 1006195 (2473260), 1007028 (2494621), 1007132 (2505492), 1007365 (2521813), 1007374 (2521824), 1008200 (2521842), 1008272 (2548567), 1010125 (2609442), 1010211 (2619061), 1010379 (2635683), 1011117 (2653292), 1011242 (2662145), 905179 (1999111), 905304 (2022225), 906031 (2024204), 906034 (2024207), 906223 (2045289), 906317 (2050127), 906322 (2050137), 907174 (2075689), 907224 (2079809), 907410 (2096921), 909321 (2155644), 910002 (2165983), 910217 (2183849), 910315 (2193854), 910405 (2197500), 911071 (2205929), 911272 (2225075),912004 (2242895), 912242 (2265319), 912357 (2270548), 1001032 (2272542), 1001122 (2282233), 1001325 (2299787), 1002031 (2308780), 1002192 (2324932), 1002262 (2332074), 1002348 (2342702), 1003049 (2346515), 1003161 (2362100), 1003276 (2371680), 1003329 (2375786), 1003334 (2376015), 1003340 (2376022), 1004239 (2399012), 1004326 (2412777), 1005001 (2421350), 1005176 (2434535), 1005318 (2447043), 1006068 (2456705), 1006106 (2463036), 1006190 (2473255), 1006315 (2480387), 1007021 (2494612), 1007128 (2505486), 1007363 (2521808), 1007370 (2521819), 1008019 (2521827), 1008195 (2521834), 1009017 (2555280), 1009280 (2592199), 1009383 (2600148), 1010123 (2609440), 1010206 (2619056), 1010377 (2635681), 1011076 (2644159), 1011114 (2653289).   Pack Lot #s: 35207, 35317, 35560, 35853, 35995, 36146, 36302, 36467, 36614, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807, 35207 35317, 35560, 35853,35995, 35995-36146, 36146, 36302, 36467, 36614, 36763, 36614, 36614/36763, 36763, 36903, 37026, 37162, 37273, 37400, 37673, 37807.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
  • Description du dispositif
    REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 || Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs
  • Manufacturer
    Nurse Assist, Inc

Manufacturer

Nurse Assist, Inc
  • Adresse du fabricant
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • Société-mère du fabricant (2017)
    Nurse Assist Inc.
  • Source
    USFDA