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).
Recall
- Recall Number
- Z-1699-2011
- Event Number
- 58075
- Firm
- Medtronic Xomed, Inc.
- FEI Number
- 1045254
- Product Code
- EPP
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- February 21, 2011
- Posted
- March 17, 2011
- Terminated
- April 3, 2012
- Address
- 6743 Southpoint Dr N, Jacksonville, FL, 32216-6218
Description
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).
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
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.
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.
26,305 units (5,261 boxes)