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U.S. Department of Health and Human Services

Class 1 Device Recall SP78100, SP78105 Nasal Septal Button Standard (3cm)

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 Class 1 Device Recall SP78100, SP78105 Nasal Septal Button Standard (3cm)see related information
Date Initiated by FirmMarch 15, 2010
Date PostedNovember 18, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall NumberZ-0347-2011
Recall Event ID 56874
510(K)NumberK982667 
Product Classification Button, nasal septal - Product Code LFB
ProductSP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385. Nasal Products, Catalog Number SP-78105, Nasal Septal Button Oversize (5cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385.
Code Information Model / Lot #: SP78100 / 114149, SP78105 / 114219.  
Recalling Firm/
Manufacturer		 Micromedics, Inc.
1270 Eagan Industrial Rd Ste 120
Eagan MN 55121-1385
For Additional Information Contact
651-452-1977 Ext. 226
Manufacturer Reason
for Recall		Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.
FDA Determined
Cause 2		Packaging process control
ActionMicromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement. Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.
Quantity in Commerce22
DistributionNationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LFB
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