An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part

FDA device recall Z-1699-2011 · posted 2011-03-17 · Terminated

Recall details

Recalling firm

Medtronic Xomed, Inc.

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

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

EPP

Quantity affected

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, Lat

Date initiated

2011-02-21

Date posted

2011-03-17

Date terminated

2012-04-03

Location

Jacksonville, FL