Events

Recall of Foam Fog Shield Surgical Mask Green Fiberglass Free

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Precept Medical Products, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0154-2008
  • Event Initiated Date
    2007-09-14
  • Event Date Posted
    2007-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65467
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical Mask - Product Code FYA
  • Reason
    Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff.
  • Action
    The firm notified its consignees on 09/14/2007 by Urgent Voluntary Medical Device Recall letter (USPS mail, certified, return-receipt requested). The recall was expanded on 10/04/2007 by Urgent Voluntary Medical Device Recall--Expansion Letter to include additional lots of product. Recall letters instruct users to cease use of devices and return them as well as conduct sub-recalls to the users level for any devices they have sub-distributed.

Device

Foam Fog Shield Surgical Mask Green Fiberglass Free
  • Model / Serial
    Lot Numbers: 1060800 through 1060890, 1060170, 1060180, 1060190, 1060200, 1060230, 1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060330, 1060340, 1060380, 1060390, 1060400, 1060410, 1060440, 1060450, 1060460, 1060470, 1060510, 1060520, 1060530, 1060540, 1060580, 1060590, 1060600, 1060610, 1060620, 1060650, 1060660, 1060670, 1060680, 1061170, 1061530, 1061560, 1061720, 1071730, 1061790, 1061880, 1061990, 1062000, 1062010, 1062070, 1062080, 1062230, 1062260, 1062270, 1062400, 1062410, 1062420, 1062470, 1062480, 1062540, 1062550, 1062560, 1062620, 1062630, 1062680, 1062690, 1062700, 1062760, 1063310, 1063320, 1063330, 1063340, 1063380, 1063390, 1070250, 1070260, 1070270, 1070330, 1070340, 1070360, 1070370, 1071370, 1071380, 1071420, 1071520, 1071590, 1071870, 1072010, 1072090, 1072140, 1072150, 1072180, 1072210, 1072220, 1072290, 1072300, 1072370, 1072390, 1072580
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide; USA, Australia and Canada
  • Product Description
    Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box, 6 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico
  • Manufacturer
    Precept Medical Products, Inc.

Manufacturer

Precept Medical Products, Inc.
  • Manufacturer Address
    Precept Medical Products, Inc., 370 Airport Rd, Arden NC 28704-9202
  • Source
    USFDA