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U.S. Department of Health and Human Services

Class 3 Device Recall Inovel 3000 series Healthcare N95 Particulate Respirator and Surgical Mask

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  Class 3 Device Recall Inovel 3000 series Healthcare N95 Particulate Respirator and Surgical Mask see related information
Date Initiated by Firm February 20, 2006
Date Posted March 03, 2006
Recall Status1 Terminated 3 on January 29, 2007
Recall Number Z-0587-06
Recall Event ID 34658
510(K)Number K051182  
Product Classification Respirator, Surgical - Product Code MSH
Product Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
Code Information Lot Number 051130-161
Recalling Firm/
Manufacturer		 Inovel LLC
10111 Jefferson Blvd
Culver City CA 90232-3509
For Additional Information Contact William Wawrzyniak
866-546-6835 Ext. 705
Manufacturer Reason
for Recall		 Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number
FDA Determined
Cause 2		 Other
Action The recalling process will be initiated by 2/22/06. Distributors will be notified of the recall through a certified recall letter and they will in turn notify and recall product from their customers and return all affected product to Inovel.
Quantity in Commerce 40 cases ( 6, 400 respirators )
Distribution Nationwide (CA, FL, ME, NY, OH, WI)
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.
510(K) Database 510(K)s with Product Code = MSH and Original Applicant = INOVEL LLC
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