Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Foam Fog Shield Surgical Mask Green Fiberglass Free

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Foam Fog Shield Surgical Mask Green Fiberglass Free see related information
Date Initiated by Firm September 14, 2007
Date Posted December 28, 2007
Recall Status1 Terminated 3 on September 11, 2009
Recall Number Z-0154-2008
Recall Event ID 45435
Product Classification Surgical Mask - Product Code FYA
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 Precept Medical Products, Inc.
370 Airport Rd
Arden NC 28704-9202
For Additional Information Contact Richard Osier
828-681-0209 Ext. 411
Manufacturer Reason
for Recall		 Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 11,546,350 (both products-Z-0153/0154-2008)
Distribution Worldwide; USA, Australia and Canada
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.
-
-