Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.

FDA Recall Z-1576-2009 · Posted 2009-07-13

Recalling FirmInovel LLC
Recall StatusTerminated
Product CodeMSH
Date Initiated2008-07-23
Date Terminated2009-07-17
Product Quantity80 cases

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

US (Illinois only).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042267INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LPInovel, LLC · 2004-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑