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U.S. Department of Health and Human Services

Class 2 Device Recall Nasal Splint

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  Class 2 Device Recall Nasal Splint see related information
Date Initiated by Firm February 21, 2011
Date Posted March 17, 2011
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-1700-2011
Recall Event ID 58075
Product Classification Splint, nasal - Product Code EPP
Product 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.***
Code Information 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        
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 2		 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 8,385 units (1,677 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.
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