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
This recall has been terminated (originally issued December 28, 2007).
- Company
- Precept Medical Products, Inc.
- Recall Initiated
- September 14, 2007
- Posted
- December 28, 2007
- Terminated
- September 11, 2009
- Recall Number
- Z-0154-2008
- Quantity
- 11,546,350 (both products-Z-0153/0154-2008)
- Firm Location
- Arden, NC
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide; USA, Australia and Canada
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.