Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
FDA Recall Z-0587-06 · Posted 2006-03-03
Recalling FirmInovel LLC
Recall StatusTerminated
Product CodeMSH
Date Initiated2006-02-20
Date Terminated2007-01-29
Product Quantity40 cases ( 6, 400 respirators )
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
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide (CA, FL, ME, NY, OH, WI)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.