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

• Date Initiated by Firm: February 20, 2006
• Date Posted: March 03, 2006
• Recall Status: Terminated 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
• FEI Number: 1000098753
• 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: 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