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
FDA Recall Z-0154-2008 · Posted 2007-12-28
Recalling FirmPrecept Medical Products, Inc.
Recall StatusTerminated
Product CodeFYA
Date Initiated2007-09-14
Date Terminated2009-09-11
Product Quantity11,546,350 (both products-Z-0153/0154-2008)
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
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide; USA, Australia and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.