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 |
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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.
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510(K) Database | 510(K)s with Product Code = MSH
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