BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0154-2008 · Initiated September 14, 2007

    Recall

    Recall Number
    Z-0154-2008
    Event Number
    45435
    Firm
    Precept Medical Products, Inc.
    FEI Number
    1018223
    Product Code
    FYA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 14, 2007
    Posted
    December 28, 2007
    Terminated
    September 11, 2009
    Address
    370 Airport Rd, Arden, NC, 28704-9202

    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

    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.

    Distribution

    Worldwide; USA, Australia and Canada

    Quantity

    11,546,350 (both products-Z-0153/0154-2008)