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U.S. Department of Health and Human Services

Class 3 Device Recall INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR

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  Class 3 Device Recall INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR see related information
Date Initiated by Firm July 23, 2008
Date Posted July 13, 2009
Recall Status1 Terminated 3 on July 17, 2009
Recall Number Z-1576-2009
Recall Event ID 52170
510(K)Number K042267  
Product Classification Respirator, surgical - Product Code MSH
Product Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
Code Information Lot Number: 060713-244.
Recalling Firm/
Manufacturer
Inovel LLC
10111 Jefferson Blvd
Culver City CA 90232-3509
For Additional Information Contact
866-546-6835
Manufacturer Reason
for Recall
Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.
FDA Determined
Cause 2
Packaging process control
Action The recalling process was initiated on July 23, 2007. The affected distributor was notified of the recall through a certified recall letter with an attached Customer Response card. The distributor was instructed to notify and obtain recall product from their customers and return all affected product to Inovel. Direct questions about the recall to Inovel at 1-866-546-6835.
Quantity in Commerce 80 cases
Distribution US (Illinois only).
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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