Events

Recall of Device Recall Nasal Splint

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Xomed, 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
    58075
  • Event Risk Class
    Class 2
  • Event Number
    Z-1700-2011
  • Event Initiated Date
    2011-02-21
  • Event Date Posted
    2011-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98265
  • 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
    Splint, nasal - Product Code EPP
  • Reason
    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
  • Model / Serial
    All Lots of alcohol pad supplied in the following kits:  REF: 1529100 (sm):  35264300 56072300 59748000 63338900 67148300 45672700 56229600 59887300 63390900 67187000 46559700 56893700 60114300 63594300 67255600 52740600 57094300 60494400 63937800 67685400 53030400 57501500 60748000 64257100 67732700 53120200 57637900 61031000 64617300 68011400 53593000 57943500 61417800 64917800 68051600 53799400 58177600 61903200 65072500 68124600 53960600 58414100 62128800 65482200 68214500 55026000 58969400 62487300 65723200 68779200 55301100 58971000 62988600 66033900  55746000 59329100 63138100 66102500.   REF: 1529110 (med):  32765300 55409300 59620200 62294300 65332500 36977500 55610700 59747600 62451300 65629400 45275000 55846300 59826600 62486600 65836900 45672800 56071000 60114100 62849200 65954400 46725100 56308700 60156500 62892000 66006700 51269600 56546300 60225400 63075400 66187600 53119700 56840300 60494300 63265400 66259300 53304100 56978500 60495500 63339200 66434800 53411800 57166400 60514000 63391000 66521600 53423800 57341200 60747600 63475600 67071500 53938600 57501400 60840900 63772200 67326300 53962000 57676800 61030800 63852800 67500900 54038800 58187700 61417600 63937600 67873100 54359500 58969000 61570900 64257400 68657800 54597900 59076100 61639500 64333000 68842900 54864100 59291100 61858800 64918000  54905500 59513600 62128600 65139000.   REF 1529120 (lg):  46873800 54863800 58189400 61906500 64918400 47201900 55409700 58970200 62128900 65481900 51303300 55801200 59076400 62451600 65671500 52930000 55846600 59577300 62491600 66034500 53064800 56231100 59826300 63076000 66684000 53158700 56546800 60156900 63176600 68873800 53353000 56893800 60494200 63390800  53800000 57094000 60748100 63475700  54170800 57501200 61031400 63708700  54352600 58177900 61639100 64332700
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    Recall of Alcohol Pads contained in the following kits distributed by Medtronic: || ***REF 1529100***Thermasplint Kit, Small***X5***. || ***REF 1529110***Thermasplint Kit, Medium***X5***. || ***REF 1529120***Thermasplint 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.***
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Manufacturer Address
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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