Events

Rappel de Device Recall Nasal Splint

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 Medtronic Xomed, 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
    58075
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1699-2011
  • Date de mise en oeuvre de l'événement
    2011-02-21
  • Date de publication de l'événement
    2011-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98263
  • 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
    Splint, nasal - Product Code EPP
  • Cause
    Medtronic xomed, inc. jacksonville, fl issued a recall on feb 21, 2011 for all lots of the alcohol pad packaged with the medtronic's external nasal splints ref 1528116 (sm), 1528126 (med), 1528136 (lg) and the thermasplints ref 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from jan 2008 through aug 2010. the alcohol supplier, cardinal health, issued a recall on the alcohol pads on jan.
  • Action
    Medtronic Xomed, Inc. sent an URGENT PRODUCT SAFETY ADVISORY (PSA) letter dated February 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately discontinue use and dispose of the alcohol prep pad co-packaged in their External Nasal Splint or Thermasplint kits. If there has been further distribution of this item, the Urgent Product Safety Advisory letter should be forwarded to the appropriate recipient. For any questions regarding this recall call 904-279-7532.

Device

Device Recall Nasal Splint
  • Modèle / numéro de série
    All Lots of alcohol pad supplied in the following kits:  REF: 1528116 (sm):  29435400 56546900 59577800 62129000 64918600 51350700 56622000 59748100 62491500 65206800 53799600 57312400 59887500 62647600 65482100 54038700 57520700 60156800 62892100 66033700 54597800 57540700 60494800 63137800 66336700 54991100 57676700 60708300 63481200 66814000 55301000 58005700 61032000 63707800 67838900 55610900 58188100 61532100 63937700 67940600 56072200 58970000 61888600 64257500 68658000 56229700 59328700 61938500 64615900 68918600.   REF 1528126 (med):  36361500 54818200 58360300 62548400 65917800 43037100 54863900 58646400 62821300 66124900 44818300 55151800 58687600 63159400 66474100 45129900 55242200 59075900 63338600 66933800 50667000 55409500 59619200 63519800 67255300 51270000 56072400 59886900 63852400 67577700 52341200 56307900 60519300 63852600 67815500 52669500 56546500 61026800 64144700 67877800 53120100 56893600 61241400 64615400 67878000 53381200 57094500 61419000 64758400 68567600 53712500 57637600 61905500 64863900 68935700 53799500 57943700 61938600 65206000 68959300 54501300 58004000 62293100 65206100.   REF 1528136 (lg):  31477100 54817800 59328800 61888900 65482000 39187500 54863300 59513800 62295000 65671400 44987900 54905400 59747800 62704800 66288600 51897300 56309000 59887200 62821400 66996400 52303000 56372500 60113000 63475900 67081600 52801000 56495500 60225500 63775400 67814800 52981200 57312500 60494500 64332900 68534100 53158900 57385900 60513700 64625000 68823100 53711700 58189000 61026400 64748800 68843200 53800300 58970100 61359800 64918100  53896300 59076300 61639600 65206900.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Singapore, Canada, Belgium, Croatia, Cyprus, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Martinique, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, Taiway, Korea, Puerto Rico, and Costa Rica.
  • Description du dispositif
    An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. || An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. || Recall of Alcohol Pads contained in the following kits distributed by Medtronic: || ***REF 1528116***External Nasal Splint Kit, Small***X5***. || ***REF 1528126***External Nasal Splint Kit, Medium***X5***. || ***REF 1528136***External Nasal Splint Kit, Large***X5***. || RECALLED PRODUCT - Front: || ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. || RECALLED PRODUCT - Back: || ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.*** || Each Kit Includes the dorsum pad (splint), an alcohol sponge (prep pad), skin preparation and skin closure tapes (steri-strips).
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Adresse du fabricant
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA