Class 2 Device Recall Nasal Splint

• Date Initiated by Firm: February 21, 2011
• Date Posted: March 17, 2011
• Recall Status: Terminated on April 03, 2012
• Recall Number: Z-1699-2011
• Recall Event ID: 58075
• Product Classification: Splint, nasal - Product Code EPP
• Product: 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).
• Code Information: 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.
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• For Additional Information Contact: David M. Timlin; 904-296-9600
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Material/Component Contamination
• 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.
• Quantity in Commerce: 26,305 units (5,261 boxes)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.